Cleared Traditional

K172241 - Tyece OTC EMS System, Model EM35 (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172241 · Tyece , Ltd. · Physical Medicine device
Nov 2017
Decision
117d
Days
Class 2
Risk

K172241 is an FDA 510(k) clearance for the Tyece OTC EMS System, Model EM35. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Tyece , Ltd. (Kowloon, HK). The FDA issued a Cleared decision on November 20, 2017 after a review of 117 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.

Submission Details

510(k) Number K172241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2017
Decision Date November 20, 2017
Days to Decision 117 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 151d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 22
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K172241.
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
TENS and EMS Unit
K251706 · Changsha Anxiang Medical Technology Co., Ltd. · Jul 2025