Cleared Special

K072294 - SYSTEM-MINI, MODELS: 390, E30

K072294 is an FDA 510(k) clearance for SYSTEM-MINI, 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 70-day FDA review.

K072294 · Bio-Medical Research, Ltd. · Physical Medicine device
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Oct 2007
Decision
70d
Days
Class 2
Risk

K072294 is an FDA 510(k) clearance for the SYSTEM-MINI, MODELS: 390, E30. 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 October 25, 2007 after a review of 70 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.

View all Bio-Medical Research, Ltd. devices

FDA 510(k) Submission Details - K072294

510(k) Number K072294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2007
Decision Date October 25, 2007
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
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 141
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K072294.
SYSTEM-ARMS, MODELS 390, X60
K083164 · Bio-Medical Research, Ltd. · Dec 2008
OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412
K072168 · Well-Life Healthcare Limited · Dec 2007
SYSTEM-ARMS, MODEL 390,E60
K072553 · Bio-Medical Research, Ltd. · Dec 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