Cleared Abbreviated

K123075 - BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B

Also marketed or referenced as:
BUTTOCK MUSCLE STIMULATOR MODE WL-2413E

K123075 is an FDA 510(k) clearance for BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B, manufactured by Well-Life Healthcare Limited. The device is a Class 2 Physical Medicine device with product code NGX cleared through the Abbreviated 510(k) pathway after a 283-day FDA review.

K123075 · Well-Life Healthcare Limited · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
283d
Days
Class 2
Risk

K123075 is an FDA 510(k) clearance for the BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B. 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 July 11, 2013 after a review of 283 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Well-Life Healthcare Limited devices

FDA 510(k) Submission Details - K123075

510(k) Number K123075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2012
Decision Date July 11, 2013
Days to Decision 283 days
Submission Type Abbreviated
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
168d slower than avg
Panel avg: 115d · This submission: 283d
Pathway characteristics
Standards-based clearance path.

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 109
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K123075.
EM25 - glute toning device
K143737 · Hivox Biotek, Inc. · Jul 2015
HIVOX SPOPAD EMS
K141921 · Hivox Biotek, Inc. · Jan 2015
OTC EMS STIMULATOR
K133965 · Shenzhen Dongdixin Technology Co., Ltd. · Jun 2014
WELL-LIFE OTC EMS SYSTEM
K102786 · Well-Life Healthcare Limited · Jul 2011
SLENDERTONE FLEX MAX, MODEL 517 US
K100556 · Bio-Medical Research, Ltd. · Aug 2010
SLENDERTONE SYSTEM ULTRA MODEL E70/X70
K100320 · Bio-Medical Research, Ltd. · May 2010