Cleared Traditional

Tens & Ems Device (TU1080)

K242787 · Changsha Anxiang Medical Technology Co., Ltd. · Physical Medicine

Dec 2024

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K242787 is an FDA 510(k) clearance for the Tens & Ems Device (TU1080), 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 December 18, 2024, 93 days after receiving the submission on September 16, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K242787 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2024
Decision Date	December 18, 2024
Days to Decision	93 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.