TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)— 510(k) K260425

Substantially Equivalent

Hivox 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..

Clearance details

Applicant: Hivox Biotek, Inc.
Product code: Code NUH
Advisory panel: Neurology
Date received: 2026-02-10
Decision date: 2026-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

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