Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2— 510(k) K221384

Substantially Equivalent

Hivox Biotek, Inc.

FDA 510(k) clearance K221384 for Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2, Substantially Equivalent on 2022-06-11. Applicant: Hivox Biotek, Inc.. Device class: 2.

Clearance details

Applicant
Hivox Biotek, Inc.
Product code
Code NUH
Device class
Class 2
Regulation
21 CFR 882.5890
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
New Taipei City, TW
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