510(k) K260425 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
| Applicant | Hivox Biotek, Inc., New Taipei City, TW |
| Decision | Substantially Equivalent, Jun 16, 2026 |
| Received | Feb 10, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260425
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.