# K170132: MyoCycle Home, MyoCycle Pro

- Pathway: 510(k) (Traditional)
- Applicant: Myolyn, LLC
- Decided: Apr 25, 2017 after 98 days
- Product code: GZI (Stimulator, Neuromuscular, External Functional)
- Device class: 2
- Regulation: 21 CFR 882.5810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K841112 (1984). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050036: Fes Cycle Ergometer, Model RT300-S, Restorative Therapies, Inc. (2005) Summary page 4.

## Most influential descendants
- K213925: MyoCycle MC-2 (Home / Home + / Pro / Pro +) (2022), 0 descendants of its own

## Indications for use
The MyoCycle is intended for general rehabilitation for: 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Maintaining or increasing range of motion

Source page: https://510kreport.com/device/K170132
Methodology: https://510kreport.com/methodology