K220217 is an FDA 510(k) clearance for the Normatec 3. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by NormaTec Industries, LP (Watertown, US). The FDA issued a Cleared decision on February 25, 2022, 30 days after receiving the submission on January 26, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K220217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2022 |
| Decision Date | February 25, 2022 |
| Days to Decision | 30 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 |