510(k) K130802 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
| Applicant | Shenzhen Dongdixin Technology Co., Ltd., Shenzhen, Guangdong, CN |
| Decision | Substantially Equivalent, Sep 16, 2013 |
| Received | Mar 22, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130802
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.