Heating Tens, FT-615— 510(k) K232675

Substantially Equivalent

Hivox Biotek, Inc.

FDA 510(k) clearance K232675 for Heating Tens, FT-615, Substantially Equivalent on 2023-10-05. 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: 2023-09-01
Decision date: 2023-10-05
Decision: Substantially Equivalent
Clearance type: Special
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.