510(k) · Cleared
ClearedRevitive Medic Coach (Model Number 5575AQ)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Actegy, Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Dec 17, 2021 after a 273-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Dec 17, 2021
- Review
- 273 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK210825 Revitive Medic Coach (Model Number 5575AQ)Actegy, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK220998 Transcutaneous Electrical Nerve Stimulator, Model: KTR-405Shenzhen Kentro Medical Electronics Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK222870 Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031…Shenzhen Kentro Medical Electronics Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See all- K220998Transcutaneous Electrical Nerve Stimulator, Model: KTR-405Shenzhen Kentro Medical Electronics Co., Ltd. · 2022 · cites it directly1descendant
- K222870Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012…Shenzhen Kentro Medical Electronics Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K210825 | Revitive Medic Coach (Model Number 5575AQ) | Actegy, Ltd. | 2021 | — |
| +1 | K220998 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 | Shenzhen Kentro Medical Electronics Co., Ltd. | 2022 | — |
| +2 | K222870 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032… | Shenzhen Kentro Medical Electronics Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
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 NGX? 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 NGX device
- #1 K250146 SofWave Systemscore 15.5 · 12 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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220998 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 | 2022 | 1 |
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.
What does this lineage say?
- Of its descendants, K220998 (Shenzhen Kentro Medical Electronics Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NGX devicesNGX Stimulator, Muscle, Powered, For Muscle Conditioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NGX
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGX
93in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGX
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NGX
15in 2025
MAUDE reports naming product code NGX, 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 | 7 | 135 | 0 | 0 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 4 | 132 | 0 | 0 |
| 2010 | 6 | 180 | 0 | 0 |
| 2011 | 5 | 291 | 0 | 1 |
| 2012 | 3 | 362 | 0 | 0 |
| 2013 | 6 | 269 | 2 | 1 |
| 2014 | 6 | 298 | 0 | 0 |
| 2015 | 9 | 184 | 0 | 7 |
| 2016 | 4 | 240 | 0 | 21 |
| 2017 | 10 | 108 | 0 | 2 |
| 2018 | 6 | 104 | 0 | 6 |
| 2019 | 14 | 167 | 0 | 4 |
| 2020 | 11 | 207 | 0 | 7 |
| 2021 | 12 | 256 | 0 | 5 |
| 2022 | 6 | 307 | 0 | 7 |
| 2023 | 12 | 96 | 0 | 8 |
| 2024 | 12 | 207 | 0 | 11 |
| 2025 | 15 | 93 | 0 | 15 |
| 2026 | 4 | 118 | 0 | — |
What is it indicated for?
(1) When using Electrical Muscle Stimulation (NMES), Revitive is intended: » for users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankles/feet, NMES though the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping * to temporarily increase local blood circulation in healthy leg muscles * to…
Read the full statement (233 words)
(1) When using Electrical Muscle Stimulation (NMES), Revitive is intended:
» for users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankles/feet, NMES though the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping
* to temporarily increase local blood circulation in healthy leg muscles
* to stimulate healthy muscles in order to improve and facilitate muscle performance
* to 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
» for relaxation of muscle spasm,
» for increase of blood flow circulation,
» for prevention or retardation of disuse atrophy,
» for muscle re-education,
» for maintaining or increasing range of motion, and
» Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
* Provide quadricep strengthening
» Improve knee stability secondary to quadricep strengthening
(2) When using Revitive to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide:
» symptomatic relief and management of chronic, intractable pain
» relief of pain associated with arthritis
* temporary relief of 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 activities.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210825 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210825: Revitive Medic Coach (Model Number 5575AQ).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210825
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026