SANIDAD TENS-DUO MODE GP8016N— 510(k) K021430

Name: FDA 510(k) clearance K021430
Creator: U.S. Food and Drug Administration
Published: 2002-12-02

Substantially Equivalent

Rolor Electronics Corp.

FDA 510(k) clearance K021430 for SANIDAD TENS-DUO MODE GP8016N, Substantially Equivalent on 2002-12-02. Applicant: Rolor Electronics Corp.. Device class: 2.

Clearance details

Applicant: Rolor Electronics Corp.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2002-05-03
Decision date: 2002-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin-Chu City, TW

Download summary PDF View on FDA.gov ↗

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