TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)— 510(k) K260425
Substantially EquivalentHivox Biotek, Inc.
FDA 510(k) clearance K260425 for TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237), Substantially Equivalent on 2026-06-16. Applicant: Hivox Biotek, Inc.. Device class: 2.
Summary
Hivox Biotek's TENS / EMS DEVICE (FT-247 Series) is listed in two models, FT-247 and FT-237. It's filed under NUH, over-the-counter transcutaneous nerve stimulators, and the record doesn't say how the models differ.
Class II, 21 CFR 882.5890. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Hivox filed from New Taipei City, Taiwan. Review took 126 calendar days (February 10 to June 16, 2026).
Clearance details
- Applicant
- Hivox Biotek, Inc.
- Product code
- Product code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Taipei City, TW
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More clearances from Hivox Biotek, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.