HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2— 510(k) K203574

Name: FDA 510(k) clearance K203574
Creator: U.S. Food and Drug Administration
Published: 2021-03-10

Substantially Equivalent

Hivox Biotek, Inc.

FDA 510(k) clearance K203574 for HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2, Substantially Equivalent on 2021-03-10. 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: 2020-12-07
Decision date: 2021-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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