Cleared Traditional

MUSCLE PAIN DEVICE (MPD) (K073361) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 73
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K073361.
geko T-2 and geko Plus R-2
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HPM-6000
K160992 · BTL Industries, Inc. · Oct 2016
SMITH & NEPHEW RESTIM
K003596 · Smith & Nephew, Inc. · Jun 2001
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436 · Medtronic Vascular · May 1992