The following data is part of a premarket notification filed by Myolyn, Llc with the FDA for Myocycle Home, Myocycle Pro.
| Device ID | K170132 |
| 510k Number | K170132 |
| Device Name: | MyoCycle Home, MyoCycle Pro |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | MYOLYN, LLC 7731 W. Newberry Rd., Suite A-2 Gainesville, FL 32606 |
| Contact | Matthew Bellman |
| Correspondent | Matthew Bellman MYOLYN, LLC 7731 W. Newberry Rd., Suite A-2 Gainesville, FL 32606 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-17 |
| Decision Date | 2017-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861553000400 | K170132 | 000 |