Cleared Traditional

K083105 - KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411

K083105 is an FDA 510(k) clearance for KNEEHAB XP CONDUCTIVE GARMENT, manufactured by Bio-Medical Research, Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K083105 · Bio-Medical Research, Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
277d
Days
Class 2
Risk

K083105 is an FDA 510(k) clearance for the KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Bio-Medical Research, Ltd. (Galway, IE). The FDA issued a Cleared decision on July 24, 2009 after a review of 277 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.

View all Bio-Medical Research, Ltd. devices

FDA 510(k) Submission Details - K083105

510(k) Number K083105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2008
Decision Date July 24, 2009
Days to Decision 277 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
162d slower than avg
Panel avg: 115d · This submission: 277d
Pathway characteristics
Predicate-based equivalence.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Physical Medicine devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00738010 Completed Interventional Industry-sponsored

Effectiveness of Kneehab in Strengthening Quadriceps in Rehabilitation Post Anterior Cruciate Ligament (ACL) Reconstruction

The Effectiveness of Kneehab in Strengthening the Quadriceps of Patients in Rehabilitation After Anterior Cruciate Ligament Reconstruction

131
Patients (actual)
1
Site
Treatment
Purpose
Single blind
Masking
Condition studied Anterior Cruciate Ligament Reconstruction
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Bio-Medical Research, Ltd. (industry)
Started 2005-04-01 → Primary completion 2006-10-01
Primary outcome
Isokinetic strength test of extension of the injured leg. Relative strength extension ratio (injured/uninjured). Distance of the jump achieved in the single leg hop and the time to achieve the shuttle run.
Secondary outcome
Strength test of flexors of the knee joint and 5 tests of coordination and proprioception (triple hop; side-step; carioca; timed hop and cross-over hop).
Study completed - no results published. This trial concluded in 2006 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 257
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K083105.
LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR
K100117 · Shenzhen Dongdixin Technology Co., Ltd. · Jan 2010
KNEEHAB XP CONTROLLER, MODEL 411
K092791 · Bio-Medical Research, Ltd. · Dec 2009
MAXEMS, MODELS 1000 AND 2000
K091248 · Bio Protech, Inc. · Nov 2009
VECTRA GENISYS VMS FR
K062354 · Encore Medical, L.P. · Jan 2007
MYOTRAC INFINITI
K053266 · Thought Technology , Ltd. · Dec 2005
EASYSTIM NMS-28
K050921 · Easy Med Instrument Co., Ltd. · Dec 2005