K202693 is an FDA 510(k) clearance for the NeoWave Pain Relief and Recovery System, Model# T16-2020. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Eva Medtec, Inc. (Bloomington, US). The FDA issued a Cleared decision on March 5, 2021, 171 days after receiving the submission on September 15, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K202693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2020 |
| Decision Date | March 05, 2021 |
| Days to Decision | 171 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 |