Cleared Traditional

K062354 - VECTRA GENISYS VMS FR

K062354 is the FDA 510(k) clearance for VECTRA GENISYS VMS FR by Encore Medical, L.P.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K062354 · Encore Medical, L.P. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
165d
Days
Class 2
Risk

K062354 is an FDA 510(k) clearance for the VECTRA GENISYS VMS FR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Encore Medical, L.P. (Hixson, US). The FDA issued a Cleared decision on January 26, 2007 after a review of 165 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 Encore Medical, L.P. devices

Submission Details

510(k) Number K062354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2006
Decision Date January 26, 2007
Days to Decision 165 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
50d slower than avg
Panel avg: 115d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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. 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 - IPF Stimulator, Muscle, Powered

All 155
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K062354.
EMPI CONTINUUM
K093324 · Empi · Mar 2010
KNEEHAB XP CONTROLLER, MODEL 411
K092791 · Bio-Medical Research, Ltd. · Dec 2009
KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411
K083105 · Bio-Medical Research, Ltd. · Jul 2009
NEUROTECH KNEEHAB
K024258 · Bio-Medical Research, Ltd. · Mar 2005
INFINITY PLUS ELECTROTHERAPY SYSTEM
K041920 · Empi · Jan 2005
BMLS03-3
K033174 · Biomedical Life Systems, Inc. · Jun 2004