Cleared Traditional

K073361 - MUSCLE PAIN DEVICE (MPD)

K073361 is an FDA 510(k) clearance for MUSCLE PAIN DEVICE (MPD), manufactured by Stevens Proof of Concept, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K073361 · Stevens Proof of Concept, Inc. · Physical Medicine device
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Mar 2008
Decision
109d
Days
Class 2
Risk

K073361 is an FDA 510(k) clearance for the MUSCLE PAIN DEVICE (MPD). Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Stevens Proof of Concept, Inc. (Stamford, US). The FDA issued a Cleared decision on March 18, 2008 after a review of 109 days - within the typical 510(k) review window.

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 Stevens Proof of Concept, Inc. devices

FDA 510(k) Submission Details - K073361

510(k) Number K073361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2007
Decision Date March 18, 2008
Days to Decision 109 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 115d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
JEFF D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 278
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K073361.
COMBI 8 MAX
K070888 · Cec Electronica S.R.L. · Jul 2008
BIOMOVE 5000 SYSTEM
K080787 · Curatronic, Ltd. · Apr 2008
MODELS TENS 7000, EMS 7500 AND TWIN STIM
K080661 · Koalaty Products, Inc. · Mar 2008
VEINOPLUS NEUROMUSCULAR STIMULATOR
K072252 · Ad Rem Technology Sarl · Jan 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

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.