# K233046: Electrical Neuromuscular Stimulator, Cure Trio

- Pathway: 510(k) (Traditional)
- Applicant: Oriental Inspiration Limited
- Decided: Apr 19, 2024 after 207 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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

Source page: https://510kreport.com/device/K233046
Methodology: https://510kreport.com/methodology