# K210825: Revitive Medic Coach (Model Number 5575AQ)

- Pathway: 510(k) (Traditional)
- Applicant: Actegy, Ltd.
- Decided: Dec 17, 2021 after 273 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K220998: Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 (2022), 1 descendant of its own
- K222870: Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 (2023), 0 descendants of its own

## Indications for use
(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.

Source page: https://510kreport.com/device/K210825
Methodology: https://510kreport.com/methodology