510(k) · Cleared
ClearedElectrical Neuromuscular Stimulator, Cure Trio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oriental Inspiration Limited · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Apr 19, 2024 after a 207-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 19, 2024
- Review
- 207 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GZJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Cure Trio (Model: MC-310A), Rx and OTC The Cure Trio MC-310A is electrical stimulator designed for pain management and neuro muscular stimulation. a.When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the…
Read the full statement (1,912 words)
Cure Trio (Model: MC-310A), Rx and OTC
The Cure Trio MC-310A is electrical stimulator designed for pain management and neuro muscular stimulation.
a.When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain
[2] Relief of pain associated with arthritis
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
[4] Relief of post-surgical pain and post traumatic acute pain
b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended:
[1] To temporarily increase local blood circulation in healthy leg muscles
[2] To stimulate healthy muscles in order to improve and facilitate muscle performance
[3] To relax muscle spasm
[4] To increase blood flow circulation
[5] For prevention of retardation of disuse atrophy
[6] For muscle re-education
[7] For maintaining or increasing range of motion
Cure TrioModel: MC-310B), Rx and OTC
The Cure Trio MC-310B is electrical stimulator designed for pain management and neuro muscular stimulation.
a.When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain
[2] Relief of pain associated with arthritis
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
[4] Relief of post-surgical pain and post traumatic acute pain
b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended:
[1] To temporarily increase local blood circulation in healthy leg muscles
[2] To stimulate healthy muscles in order to improve and facilitate muscle performance
[3] To relax muscle spasm
[4] To increase blood flow circulation
[5] For prevention of retardation of disuse atrophy
Cure Trio (Model: MC-310C), Rx and OTC
The Cure Trio MC-310C is electrical stimulator designed for pain management and neuro muscular stimulation.
a.When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain
[2] Relief of pain associated with arthritis
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
[4] Relief of post-surgical pain and post traumatic acute pain
b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended:
[1] To temporarily increase local blood circulation in healthy leg muscles
[2] To stimulate healthy muscles in order to improve and facilitate muscle performance
[3] To relax muscle spasm
[4] To increase blood flow circulation
[5] For prevention of retardation of disuse atrophy
Cure TrioModel: MC-310D), Rx and OTC
The Cure Trio MC-310D is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain
[2] Relief of pain associated with arthritis
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
[4] Relief of post-surgical pain and post traumatic acute pain
Cure TrioModel: MC-310E, Rx and OTC
The Cure Trio MC-310E is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain
[2] Relief of pain associated with arthritis
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
[4] Relief of post-surgical pain and post traumatic acute pain
Cure TrioModel: MC-310FRx and OTC
The Cure Trio MC-310F is electrical stimulator designed for pain management and neuro muscular stimulation.
a.When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain
[2]Relief of pain associated with arthritis
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
[4] Relief of post-surgical pain and post traumatic acute pain
b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended:
[1] To temporarily increase local blood circulation in healthy leg muscles
[2] To relax muscle spasm
[3] To increase blood flow circulation
[4] For prevention of retardation of disuse atrophy
Cure TrioModel: MC-310G) Rx and OTC
The Cure Trio MC-310G is electrical stimulator designed for pain management and neuro muscular stimulation.
a.When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain
[2] Relief of pain associated with arthritis
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
[4] Relief of post-surgical pain and post traumatic acute pain
b.When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended:
[1] To temporarily increase local blood circulation in healthy leg muscles
[2] For prevention of retardation of disuse atrophy
Cure TrioModel: MC-310HRx and OTC
The Cure Trio MC-310H is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain
[2] Relief of pain associated with arthritis
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
Cure TrioModel: MC-310IRx and OTC
The Cure Trio MC-310I is electrical stimulator designed for pain management and neuro muscular stimulation.
a.When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain
[2] Relief of pain associated with arthritis
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
[4] Relief of post-surgical pain and post traumatic acute pain
b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended:
[1] To temporarily increase local blood circulation in healthy leg muscles
[2] To stimulate healthy muscles in order to improve and facilitate muscle performance
Cure TrioModel: MC-310ORx and OTC
The Cure Trio MC-310O is electrical stimulator designed for pain management and neuro muscular stimulation.
a.When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain
[2] Relief of pain associated with arthritis
[3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
[4] Relief of post-surgical pain and post traumatic acute pain
b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended:
[1] To temporarily increase local blood circulation in healthy leg muscles
[2] To stimulate healthy muscles in order to improve and facilitate muscle performance
[3] To relax muscle spasm
[4] To increase blood flow circulation
[5] For prevention of retardation of disuse atrophy
[6] For muscle re-education
[7] For maintaining or increasing range of motion
Cure TrioModel: MC-310PRx and OTC
The Cure Trio MC-310P is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain
[2] Relief of pain associated with arthritis
[3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
[4] Relief of post-surgical pain and post traumatic acute pain
Cure TrioModel: MC-310QRx and OTC
The Cure Trio MC-310Q is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain
[2] Relief of pain associated with arthritis
[3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
[4] Relief of post-surgical pain and post traumatic acute pain
Cure TrioModel: MC-310R) Rx and OTC
The Cure Trio MC-310R is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain
[2] Relief of pain associated with arthritis
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
[4] Relief of post-surgical pain and post traumatic acute pain
b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended:
[1] To temporarily increase local blood circulation in healthy leg muscles
[2] To relax muscle spasm
[3] To increase blood flow circulation
[4] For prevention of retardation of disuse atrophy
[5] For muscle re-education
[6] For maintaining or increasing range of motion
Cure TrioModel: MC-310SRx and OTC
The Cure Trio MC-310S is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain
[2] Relief of pain associated with arthritis
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
[4] Relief of post-surgical pain and post traumatic acute pain
b.When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended:
[1] To temporarily increase local blood circulation in healthy leg muscles
[2] To relax muscle spasm
[3] To increase blood flow circulation
[4] For prevention of retardation of disuse atrophy
[5] For muscle re-education
[6] For maintaining or increasing range of motion
Cure TrioModel: MC-310TRx and OTC
The Cure Trio MC-310T is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain
[2] Relief of pain associated with arthritis
[3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
Cure TrioModel: MC-310URx and OTC
The Cure Trio MC-310U is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain
[2] Relief of pain associated with arthritis
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
[4] Relief of post-surgical pain and post traumatic acute pain
b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended:
[1] To temporarily increase local blood circulation in healthy leg muscles
[2] To stimulate healthy muscles in order to improve and facilitate muscle performance
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K233046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233046: Electrical Neuromuscular Stimulator, Cure Trio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233046
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026