Cleared Traditional

K924699 - PMP MUSCLE STIMULATOR

K924699 is the FDA 510(k) clearance for PMP MUSCLE STIMULATOR by Preferred Medical Products. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K924699 · Preferred Medical Products · Physical Medicine device
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Apr 1993
Decision
225d
Days
Class 2
Risk

K924699 is an FDA 510(k) clearance for the PMP MUSCLE STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Preferred Medical Products (Gardena, US). The FDA issued a Cleared decision on April 30, 1993 after a review of 225 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.

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Submission Details

510(k) Number K924699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1992
Decision Date April 30, 1993
Days to Decision 225 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 115d · This submission: 225d
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 77
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K924699.
SMITH & NEPHEW RESTIM
K003596 · Smith & Nephew, Inc. · Jun 2001
FORTE, MODELS CPS 400 STIM, CPS 200 STIM
K982828 · Chattanooga Group, Inc. · Nov 1998
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436 · Medtronic Vascular · May 1992
INTERSTIM 100 SYSTEM
K861136 · Buckman Co., Inc. · Jul 1986
MYOCARE PLUS DUAL CHANNEL STIMULATOR
K851046 · 3M Company · Jul 1985