510(k) K253638 ยท SDO Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
xStep (xStep)
| Applicant | Spinex, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Apr 20, 2026 |
| Received | Nov 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253638
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.