Cleared Special

K251706 - TENS and EMS Unit (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251706 · Changsha Anxiang Medical Technology Co., Ltd. · Physical Medicine device
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Jul 2025
Decision
57d
Days
Class 2
Risk

K251706 is an FDA 510(k) clearance for the TENS and EMS Unit. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Changsha Anxiang Medical Technology Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on July 30, 2025 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Changsha Anxiang Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K251706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - NGX Stimulator, Muscle, Powered, For Muscle Conditioning

All 161
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K251706.
Diacore
K253926 · ShenB Co., Ltd. · Apr 2026
Zionic Pro Max (EMS)
K253636 · Termosalud S.L. · Mar 2026
CoolTone
K253408 · Zimmer Medizinsysteme GmbH · Jan 2026
Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)
K252154 · Guangzhou Longest Medical Technology Co., Ltd. · Dec 2025
Motive™ Muscle Stimulator for Lower Back (OT01-1003)
K253478 · Motive Health, Inc. · Nov 2025
truFlex
K251594 · Syrma Johari Medtech Limited · Aug 2025