Cleared Traditional

SM TENS & PMS

K121719 · Hong Qiangxing (Shenzhen) Electronics Limited · Physical Medicine

May 2013

Decision

333d

Days

Class 2

Risk

About This 510(k) Submission

K121719 is an FDA 510(k) clearance for the SM TENS & PMS, a Stimulator, Muscle, Powered, For Muscle Conditioning (Class II — Special Controls, product code NGX), submitted by Hong Qiangxing (Shenzhen) Electronics Limited (Shanghai, CN). The FDA issued a Cleared decision on May 10, 2013, 333 days after receiving the submission on June 11, 2012. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K121719 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 2012
Decision Date	May 10, 2013
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.