Cleared Traditional

POWERTONE, MODEL PT-11

K062439 · Johari Digital Healthcare , Ltd. · Physical Medicine

Jan 2007

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K062439 is an FDA 510(k) clearance for the POWERTONE, MODEL PT-11, a Stimulator, Muscle, Powered, For Muscle Conditioning (Class II — Special Controls, product code NGX), submitted by Johari Digital Healthcare , Ltd. (Calabases, US). The FDA issued a Cleared decision on January 8, 2007, 140 days after receiving the submission on August 21, 2006. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K062439 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 2006
Decision Date	January 08, 2007
Days to Decision	140 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.