510(k) K180082
K180082 is an FDA 510(k) premarket notification submitted by Firstkind, Ltd. for the device "geko T-2 and geko Plus R-2". The FDA issued a decision of Substantially Equivalent on Feb 11, 2018. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 11, 2018
- Date Received
- Jan 11, 2018
- 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)