K212491 is an FDA 510(k) clearance for the Air Relax Pro Model AR-4.0. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Diode Art Engineering Doing Business AS Air Relax (Pico Rivera, US). The FDA issued a Cleared decision on September 2, 2021, 24 days after receiving the submission on August 9, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K212491 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2021 |
| Decision Date | September 02, 2021 |
| Days to Decision | 24 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 |