510(k) K113321 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
TENS BACK PAIN RELIEF SYSTEM
| Applicant | Savia Limited, Bonita Springs FL, US |
| Decision | Substantially Equivalent, Sep 4, 2012 |
| Received | Nov 10, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113321
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.