K210281 is an FDA 510(k) clearance for the Fist Assist Devices Model FA-1. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Fist Assist Devices, LLC (Los Altos, US). The FDA issued a Cleared decision on June 17, 2021, 136 days after receiving the submission on February 1, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K210281 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2021 |
| Decision Date | June 17, 2021 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |