# K213925: MyoCycle MC-2 (Home / Home + / Pro / Pro +)

- Pathway: 510(k) (Traditional)
- Applicant: Myolyn, LLC
- Decided: Apr 25, 2022 after 130 days
- Product code: GZI (Stimulator, Neuromuscular, External Functional)
- Device class: 2
- Regulation: 21 CFR 882.5810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K841112 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170132: MyoCycle Home, MyoCycle Pro, Myolyn, LLC (2017) Summary page 4.

## Recalls of this device
- Jul 19, 2022 · Class II · Z-1523-2022: Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.

## 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 5. Muscle re-education

Source page: https://510kreport.com/device/K213925
Methodology: https://510kreport.com/methodology