Cleared Traditional

K081026 - BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5

K081026 is an FDA 510(k) clearance for BODY CONTROL SYSTEM FAMILY, manufactured by Sport-Elec S.A.. The device is a Class 2 Physical Medicine device with product code NGX cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K081026 · Sport-Elec S.A. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
209d
Days
Class 2
Risk

K081026 is an FDA 510(k) clearance for the BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5. Classified as Stimulator, Muscle, Powered, For Muscle Conditioning (product code NGX), Class II - Special Controls.

Submitted by Sport-Elec S.A. (Hampton, US). The FDA issued a Cleared decision on November 5, 2008 after a review of 209 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K081026

510(k) Number K081026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2008
Decision Date November 05, 2008
Days to Decision 209 days
Submission Type Traditional
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
93d slower than avg
Panel avg: 116d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 162
Devices cleared under the same product code (NGX) and FDA review panel - the closest regulatory comparables to K081026.
H-WAVE SPORT
K081998 · Electronic Waveform Laboratory, Inc. · Jul 2009
COMPEX SPORT PLUS
K083140 · Chattanooga Group · Feb 2009
SYSTEM-ARMS, MODELS 390, X60
K083164 · Bio-Medical Research, Ltd. · Dec 2008
SLENDERTONE ENERVIVE, MODEL 561
K071666 · Bio-Medical Research Corp. · Mar 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
K081026 · BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5
Download PDF FDA Summary Sport-Elec S.A.