510(k) K213120 ยท ISA Massager, Therapeutic, Electric
OW100S (model OW100S-US)
| Applicant | Tissue Regeneration Technologies, LLC Dba AS Softwave Trt, Woodstock GA, US |
| Decision | Substantially Equivalent, Oct 12, 2022 |
| Received | Sep 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213120
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.