Cleared Special

K083164 - SYSTEM-ARMS, MODELS 390, X60

K083164 is an FDA 510(k) clearance for SYSTEM-ARMS, 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 50-day FDA review.

K083164 · Bio-Medical Research, Ltd. · Physical Medicine device
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Dec 2008
Decision
50d
Days
Class 2
Risk

K083164 is an FDA 510(k) clearance for the SYSTEM-ARMS, MODELS 390, X60. 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 December 16, 2008 after a review of 50 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 - K083164

510(k) Number K083164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2008
Decision Date December 16, 2008
Days to Decision 50 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
65d faster than avg
Panel avg: 115d · This submission: 50d
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 K083164.
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SYSTEM-ARMS, MODEL 390,E60
K072553 · Bio-Medical Research, Ltd. · Dec 2007
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K072294 · Bio-Medical Research, Ltd. · Oct 2007