GEM-TONE BODY TRAINING SYSTEM— 510(k) K102933

Name: FDA 510(k) clearance K102933
Creator: U.S. Food and Drug Administration
Published: 2011-09-02

Substantially Equivalent

Gemore Technology Co, Ltd.

FDA 510(k) clearance K102933 for GEM-TONE BODY TRAINING SYSTEM, Substantially Equivalent on 2011-09-02. Applicant: Gemore Technology Co, Ltd.. Device class: 2.

Clearance details

Applicant: Gemore Technology Co, Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2010-10-04
Decision date: 2011-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tan Shui, 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.