510(k) K213925 ยท GZI Stimulator, Neuromuscular, External Functional
MyoCycle MC-2 (Home / Home + / Pro / Pro +)
| Applicant | Myolyn, LLC, Gainesville FL, US |
| Decision | Substantially Equivalent, Apr 25, 2022 |
| Received | Dec 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213925
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2022 | Myolyn Inc. Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2. Terminated |
GZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.