510(k) K251821 ยท SDO Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
ARC-EX System
| Applicant | Onward Medical, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Nov 14, 2025 |
| Received | Jun 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251821
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.