Cleared Traditional

FIT BELT

K133108 · Hong Qiangxing (Shenzhen) Electronics Limited · Physical Medicine

Aug 2014

Decision

309d

Days

Class 2

Risk

About This 510(k) Submission

K133108 is an FDA 510(k) clearance for the FIT BELT, a Stimulator, Muscle, Powered, For Muscle Conditioning (Class II — Special Controls, product code NGX), submitted by Hong Qiangxing (Shenzhen) Electronics Limited (Shenzhen, CN). The FDA issued a Cleared decision on August 5, 2014, 309 days after receiving the submission on September 30, 2013. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K133108 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2013
Decision Date	August 05, 2014
Days to Decision	309 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

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.