Cleared Special

K052969 - SLENDERTONE GYMBODY, MODEL 512-01

K052969 is an FDA 510(k) clearance for SLENDERTONE GYMBODY, manufactured by Bio-Medical Research, Ltd.. The device is a Class 2 Physical Medicine device with product code NGX cleared through the Special 510(k) pathway after a 26-day FDA review.

K052969 · Bio-Medical Research, Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
26d
Days
Class 2
Risk

K052969 is an FDA 510(k) clearance for the SLENDERTONE GYMBODY, MODEL 512-01. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Bio-Medical Research, Ltd. (Galway, IE). The FDA issued a Cleared decision on November 16, 2005 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K052969

510(k) Number K052969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2005
Decision Date November 16, 2005
Days to Decision 26 days
Submission Type Special
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
90d faster than avg
Panel avg: 116d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 163
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K052969.
GLOBUS PREMIUM MUSCLE STIMULATOR
K061632 · Domino S.R.L. · Apr 2007
SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10
K070142 · Bio-Medical Research Corp. · Mar 2007
POWERTONE, MODEL PT-11
K062439 · Johari Digital Healthcare , Ltd. · Jan 2007
P4-FITNESS
K031611 · Valmed Corp. · Sep 2004
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
K052969 · SLENDERTONE GYMBODY, MODEL 512-01
Download PDF FDA Summary Bio-Medical Research,…