K213120 is an FDA 510(k) clearance for the OW100S (model OW100S-US). This device is classified as a Massager, Therapeutic, Electric (Class I - General Controls, product code ISA).
Submitted by Tissue Regeneration Technologies, LLC Dba AS Softwave Trt (Woodstock, US). The FDA issued a Cleared decision on October 12, 2022, 380 days after receiving the submission on September 27, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5660.
| 510(k) Number | K213120 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2021 |
| Decision Date | October 12, 2022 |
| Days to Decision | 380 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ISA - Massager, Therapeutic, Electric |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5660 |