510(k) K213133 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Keffort (MC-100, MC-100A)
| Applicant | Oriental Inspiration Limited, Hong Kong, CN |
| Decision | Substantially Equivalent, Apr 13, 2022 |
| Received | Sep 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213133
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.