TENS/EMS COMBO, EMS, TENS— 510(k) K082514

Name: FDA 510(k) clearance K082514
Creator: U.S. Food and Drug Administration
Published: 2008-10-21

Substantially Equivalent

Medihightec Medical Co., Ltd.

FDA 510(k) clearance K082514 for TENS/EMS COMBO, EMS, TENS, Substantially Equivalent on 2008-10-21. Applicant: Medihightec Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Medihightec Medical Co., Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2008-09-02
Decision date: 2008-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keelung City, TW

Download summary PDF View on FDA.gov ↗

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