K221666 is an FDA 510(k) clearance for the Normatec Go. 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 July 14, 2022, 36 days after receiving the submission on June 8, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K221666 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2022 |
| Decision Date | July 14, 2022 |
| Days to Decision | 36 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 |