Myolyn Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1523-2022Class IIPower electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.July 19, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K213925MyoCycle MC-2 (Home / Home + / Pro / Pro +)April 25, 2022
K170132MyoCycle Home, MyoCycle ProApril 25, 2017