K211460 is an FDA 510(k) clearance for the Air Relax Plus Model AR-3.0. 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 May 25, 2021, 14 days after receiving the submission on May 11, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K211460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2021 |
| Decision Date | May 25, 2021 |
| Days to Decision | 14 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 |