Cleared Traditional

K072252 - VEINOPLUS NEUROMUSCULAR STIMULATOR

K072252 is an FDA 510(k) clearance for VEINOPLUS NEUROMUSCULAR STIMULATOR, manufactured by Ad Rem Technology Sarl. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K072252 · Ad Rem Technology Sarl · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
170d
Days
Class 2
Risk

K072252 is an FDA 510(k) clearance for the VEINOPLUS NEUROMUSCULAR STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Ad Rem Technology Sarl (Potomac, US). The FDA issued a Cleared decision on January 30, 2008 after a review of 170 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 - K072252

510(k) Number K072252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2007
Decision Date January 30, 2008
Days to Decision 170 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
54d slower than avg
Panel avg: 116d · This submission: 170d
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 422
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K072252.
BIOMOVE 5000 SYSTEM
K080787 · Curatronic, Ltd. · Apr 2008
MODELS TENS 7000, EMS 7500 AND TWIN STIM
K080661 · Koalaty Products, Inc. · Mar 2008
MUSCLE PAIN DEVICE (MPD)
K073361 · Stevens Proof of Concept, Inc. · Mar 2008
FD EMS, MODEL # D-FJ30E
K063642 · Fuji Dynamics Limited · Dec 2007
SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202
K071093 · San Shih Electrical Enterprise Co., Ltd. · Dec 2007
MODELS EMS 5.0, EMS 5.1
K072795 · Koalaty Products, Inc. · Nov 2007
K072252 · VEINOPLUS NEUROMUSCULAR STIMULATOR
Download PDF FDA Summary Ad Rem Technology Sarl