The following data is part of a premarket notification filed by Eva Medtec, Inc with the FDA for Neowave Pain Relief And Recovery System, Model# T16-2020.
| Device ID | K202693 |
| 510k Number | K202693 |
| Device Name: | NeoWave Pain Relief And Recovery System, Model# T16-2020 |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Eva Medtec, Inc 6300 W. Old Shakopee Road, Suite 140 Bloomington, MN 55438 |
| Contact | Irene Waldridge |
| Correspondent | Irene Waldridge Eva Medtec, Inc 6300 W. Old Shakopee Road, Suite 140 Bloomington, MN 55438 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-15 |
| Decision Date | 2021-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G067T1620200 | K202693 | 000 |
| G067A001500 | K202693 | 000 |