Cleared Traditional

GEM-TONE BODY TRAINING SYSTEM

K102933 · Gemore Technology Co, Ltd. · Physical Medicine

Sep 2011

Decision

333d

Days

Class 2

Risk

About This 510(k) Submission

K102933 is an FDA 510(k) clearance for the GEM-TONE BODY TRAINING SYSTEM, a Stimulator, Muscle, Powered, For Muscle Conditioning (Class II — Special Controls, product code NGX), submitted by Gemore Technology Co, Ltd. (Tan Shui, New Taipei City, TW). The FDA issued a Cleared decision on September 2, 2011, 333 days after receiving the submission on October 4, 2010. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K102933 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 04, 2010
Decision Date	September 02, 2011
Days to Decision	333 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	NGX — Stimulator, Muscle, Powered, For Muscle Conditioning
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5850
Definition	A Powered Muscle Stimulator For Muscle Conditioning Is A Device Used For Other Than Medical Purposes To Apply An Electrical Current To Electrodes On A Person's Skin To Temporarily Affect The Stimulated Muscle's Contractile Properties, Force Output, And/or Fatigue Resistance. Unlike The Classified Powered Muscle Stimulator Devices Intended For Use In Physical Medicine And Rehabilitation, This Device Is Not Intended For Use In Patients With Medical Conditions And Is Intended Only For Muscle Conditioning Purposes.