510(k) K163125
K163125 is an FDA 510(k) premarket notification submitted by Firstkind Limited for the device "geko T-2 and geko Plus R-2 Neuromuscular Stimulators". The FDA issued a decision of Substantially Equivalent on Apr 10, 2017. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Firstkind Limited has 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 10, 2017
- Date Received
- Nov 8, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type
- 510(k)