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 |