Cleared Special

truFlex

K251594 · Syrma Johari Medtech Limited · Physical Medicine

Aug 2025

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K251594 is an FDA 510(k) clearance for the truFlex, a Stimulator, Muscle, Powered, For Muscle Conditioning (Class II — Special Controls, product code NGX), submitted by Syrma Johari Medtech Limited (Jodhpur, IN). The FDA issued a Cleared decision on August 28, 2025, 93 days after receiving the submission on May 27, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K251594 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2025
Decision Date	August 28, 2025
Days to Decision	93 days
Submission Type	Special
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.