510(k) K193045
K193045 is an FDA 510(k) premarket notification submitted by Firstkind Limited for the device "geko W-2". The FDA issued a decision of Substantially Equivalent on Jan 18, 2020. 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
- Jan 18, 2020
- Date Received
- Nov 1, 2019
- Clearance Type
- Special
- 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)