510(k) K241516 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
BTL-398
| Applicant | BTL Industries, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Feb 10, 2025 |
| Received | May 29, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241516
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.