Cleared Traditional

K062354 - VECTRA GENISYS VMS FR

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

K062354 · Encore Medical, L.P. · Physical Medicine device
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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

FDA 510(k) Submission Details - K062354

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.

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. 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 274
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K062354.
EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311
K071320 · Everlife Medical Equipment Co., Ltd. · Aug 2007
VITALSTIM EXPERIA
K070425 · Chattanooga Group · Jun 2007
KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138
K062453 · Kingly Star Intl. Technology Co., Ltd. · Apr 2007
MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM
K053285 · Durtech System Corp. · Jan 2006
MYOTRAC INFINITI
K053266 · Thought Technology , Ltd. · Dec 2005
EASYSTIM NMS-28
K050921 · Easy Med Instrument Co., Ltd. · Dec 2005