Is this your brand? Sign in to claim ownership.
Sign in to claim this brandMYOLYN, INC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 6931 NW 22ND ST # A, Gainesville, FL, 32653
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3013503259
- DUNS Number
- —
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MyoCycle | MC-2 | FDA UDI | Class II | Active |
| MyoCycle Home/Pro | MC-HP-1 | FDA UDI | Class II | Active |
| MyoCycle Home, MyoCycle Pro | K170132 | FDA 510(k) | Class II | Active |
| MyoCycle MC-2 (Home / Home + / Pro / Pro +) | K213925 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 19, 2022 | Z-1523-2022 | — | terminated | Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock. |