510(k) K152852 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, Dec 22, 2015 |
| Received | Sep 29, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152852
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.