K260425
- 510(k) number
- K260425
- Device name
- TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
- Applicant
- Hivox Biotek, Inc. TW
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2026-06-16
- Date received
- 2026-02-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K260425
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.