510(k) K170132
K170132 is an FDA 510(k) premarket notification submitted by Myolyn, LLC for the device "MyoCycle Home, MyoCycle Pro". The FDA issued a decision of Substantially Equivalent on April 25, 2017. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. Myolyn, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2017
- Date Received
- January 17, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Neuromuscular, External Functional
- Device Class
- Class II
- Regulation Number
- 882.5810
- Review Panel
- NE
- Submission Type