Cleared Traditional

K070142 - SLENDERTONE SYSTEM ABS

Also marketed or referenced as:
SLENDERTONE SYSTEM SHORTS, MODELS 390, E20

K070142 is the FDA 510(k) clearance for SLENDERTONE SYSTEM ABS by Bio-Medical Research Corp.. It is a Class 2 Physical Medicine device (product code NGX) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K070142 · Bio-Medical Research Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
66d
Days
Class 2
Risk

K070142 is an FDA 510(k) clearance for the SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Bio-Medical Research Corp. (Galway, IE). The FDA issued a Cleared decision on March 23, 2007 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bio-Medical Research Corp. devices

Submission Details

510(k) Number K070142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2007
Decision Date March 23, 2007
Days to Decision 66 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 115d · This submission: 66d
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 103
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K070142.
SYSTEM-ARMS, MODELS 390, X60
K083164 · Bio-Medical Research, Ltd. · Dec 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
SLENDERTONE GYMBODY, MODEL 512-01
K052969 · Bio-Medical Research, Ltd. · Nov 2005
SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515
K030708 · Bio-Medical Research, Ltd. · Jun 2003
SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511
K022855 · Bio-Medical Research, Ltd. · Mar 2003