Cleared Special

TENS and EMS Unit

K251706 · Changsha Anxiang Medical Technology Co., Ltd. · Physical Medicine

Jul 2025

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K251706 is an FDA 510(k) clearance for the TENS and EMS Unit, a Stimulator, Muscle, Powered, For Muscle Conditioning (Class II — Special Controls, product code NGX), submitted by Changsha Anxiang Medical Technology Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on July 30, 2025, 57 days after receiving the submission on June 3, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K251706 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 2025
Decision Date	July 30, 2025
Days to Decision	57 days
Submission Type	Special
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.