510(k) K210281
K210281 is an FDA 510(k) premarket notification submitted by Fist Assist Devices, LLC for the device "Fist Assist Devices Model FA-1". The FDA issued a decision of Substantially Equivalent on Jun 17, 2021. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 17, 2021
- Date Received
- Feb 1, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Powered Inflatable Tube
- Device Class
- Class II
- Regulation Number
- 890.5650
- Review Panel
- PM
- Submission Type
- 510(k)