Cleared Traditional

K142055 - GYMFORM ABS & CORE

K142055 is an FDA 510(k) clearance for GYMFORM ABS & CORE, manufactured by Well Brain International , Ltd.. The device is a Class 2 Physical Medicine device with product code NGX cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K142055 · Well Brain International , Ltd. · Physical Medicine device
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May 2015
Decision
286d
Days
Class 2
Risk

K142055 is an FDA 510(k) clearance for the GYMFORM ABS & CORE. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Well Brain International , Ltd. (Kwai Chung, N.T., HK). The FDA issued a Cleared decision on May 11, 2015 after a review of 286 days - an extended review cycle.

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.

View all Well Brain International , Ltd. devices

FDA 510(k) Submission Details - K142055

510(k) Number K142055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2014
Decision Date May 11, 2015
Days to Decision 286 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
170d slower than avg
Panel avg: 116d · This submission: 286d
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 162
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K142055.
PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)
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Revitive IX (OTC)
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TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)
K143059 · Tone-A-Matic International, Inc. · Jan 2015