Cleared Traditional

K262470 - Dual-Channel TENS & EMS Muscle Stimulator (Models TS1111, TS4111)

K262470 is an FDA 510(k) clearance for Dual-Channel TENS & EMS Muscle Stimulat..., manufactured by Changsha Anxiang Medical Technology Co., Ltd.. The device is a Class 2 Physical Medicine device with product code NGX cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K262470 · Changsha Anxiang Medical Technology Co., Ltd. · Physical Medicine device
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Oct 2026
Decision
105d
Days
Class 2
Risk

K262470 is an FDA 510(k) clearance for the Dual-Channel TENS & EMS Muscle Stimulator (Models TS1111, TS4111). 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 October 30, 2026 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K262470

510(k) Number K262470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2026
Decision Date October 30, 2026
Days to Decision 105 days
Submission Type Traditional
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
11d faster than avg
Panel avg: 116d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NGX Device Classification - Class 2, Special Controls

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 163
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K262470.
High Intensity Focused Electromagnetic Stimulation Device (FE60)
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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
K262470 · Dual-Channel TENS & EMS Muscle Stimulator (Models TS1111, TS4111)
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