Cleared Traditional

K183103 - EMS Belt (Model MC0485)

K183103 is the FDA 510(k) clearance for EMS Belt (Model MC0485) by Dongguan Yingfeng Metal & Plastic Products Co., Ltd.. It is a Class 2 Physical Medicine device (product code NGX) cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K183103 · Dongguan Yingfeng Metal & Plastic Products Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
315d
Days
Class 2
Risk

K183103 is an FDA 510(k) clearance for the EMS Belt (Model MC0485). Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Dongguan Yingfeng Metal & Plastic Products Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on September 18, 2019 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

View all Dongguan Yingfeng Metal & Plastic Products Co., Ltd. devices

Submission Details

510(k) Number K183103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2018
Decision Date September 18, 2019
Days to Decision 315 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 115d · This submission: 315d
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 Consultant

Feiying Drug & Medical Consulting Technical Service Group
Rain Yip

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 93
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K183103.
CoolTone
K192940 · Zimmer Medizinsysteme GmbH · Nov 2019
HIVOX Spopad EMS SP-911, SP-921
K192264 · Hivox Biotek, Inc. · Nov 2019
NXPRO Neuromuscular Electrical Stimulation Device
K191181 · Neux Technologies, Inc. · Oct 2019
BionicGym Powered Muscle Stimulator
K182794 · Medical Currents, Ltd. · Jul 2019
BTL 799-2L
K190456 · BTL Industries, Inc. · Jul 2019
Revitive Medic Plus, Revitive Advanced 2
K190924 · Actegy , Ltd. · Jul 2019