510(k) K161349 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Everyway Incontinence Stimulation System
| Applicant | Everyway Medical Instrument Co., Ltd., Shenkeng District, New Taipei City, CN |
| Decision | Substantially Equivalent, Jul 7, 2017 |
| Received | May 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161349
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.