K211745 is an FDA 510(k) clearance for the RecoveryAir PRO. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Theragun, Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 4, 2021, 119 days after receiving the submission on June 7, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K211745 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2021 |
| Decision Date | October 04, 2021 |
| Days to Decision | 119 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 |