The following data is part of a premarket notification filed by Tissue Regeneration Technologies, Llc Dba As Softwave Trt with the FDA for Ow100s (model Ow100s-us).
| Device ID | K213120 |
| 510k Number | K213120 |
| Device Name: | OW100S (model OW100S-US) |
| Classification | Massager, Therapeutic, Electric |
| Applicant | Tissue Regeneration Technologies, LLC DBA As SoftWave TRT 251 Heritage Walk Woodstock, GA 30188 |
| Contact | John Warlick |
| Correspondent | Cherita James M Squared Associates, Inc 127 West 30th Street, 9th Floor New York, NY 10001 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-27 |
| Decision Date | 2022-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260484571625 | K213120 | 000 |