510(k) K171802 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
| Applicant | Bayer Healthcare, LLC, Whippany NJ, US |
| Decision | Substantially Equivalent, Mar 7, 2018 |
| Received | Jun 19, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171802
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.