Cleared Traditional

OTC TENS & EMS Unit

K243511 · Changsha Anxiang Medical Technology Co., Ltd. · Physical Medicine

Feb 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K243511 is an FDA 510(k) clearance for the OTC 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 February 10, 2025, 90 days after receiving the submission on November 12, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K243511 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2024
Decision Date	February 10, 2025
Days to Decision	90 days
Submission Type	Traditional
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.