Cleared Traditional

Wireless TENS & EMS Unit

K243763 · Changsha Anxiang Medical Technology Co., Ltd. · Neurology

Mar 2025

Decision

96d

Days

Class 2

Risk

About This 510(k) Submission

K243763 is an FDA 510(k) clearance for the Wireless TENS & 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 March 12, 2025, 96 days after receiving the submission on December 6, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K243763 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2024
Decision Date	March 12, 2025
Days to Decision	96 days
Submission Type	Traditional
Review Panel	Neurology (NE)
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.