510(k) K260412 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
TENS 7000 Rechargeable 4 Channel (TENS 7000H)
| Applicant | Shenzhen Dongdixin Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jun 26, 2026 |
| Received | Feb 9, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260412
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.