Cleared Traditional

K072168 - OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412

K072168 is an FDA 510(k) clearance for OTC ABDOMEN & THIGH SYSTEM, manufactured by Well-Life Healthcare Limited. The device is a Class 2 Physical Medicine device with product code NGX cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K072168 · Well-Life Healthcare Limited · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
135d
Days
Class 2
Risk

K072168 is an FDA 510(k) clearance for the OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Well-Life Healthcare Limited (Yunghe City, Taipei County, TW). The FDA issued a Cleared decision on December 19, 2007 after a review of 135 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 - K072168

510(k) Number K072168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2007
Decision Date December 19, 2007
Days to Decision 135 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
19d slower than avg
Panel avg: 116d · This submission: 135d
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 K072168.
SYSTEM-ARMS, MODELS 390, X60
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SLENDERTONE ENERVIVE, MODEL 561
K071666 · Bio-Medical Research Corp. · Mar 2008
SYSTEM-ARMS, MODEL 390,E60
K072553 · Bio-Medical Research, Ltd. · Dec 2007
SYSTEM-MINI, MODELS: 390, E30
K072294 · Bio-Medical Research, Ltd. · Oct 2007
SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS
K061914 · Sport-Elec S.A. · Jul 2007
K072168 · OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412
Download PDF FDA Summary Well-Life Healthcare …