Cleared Traditional

K940301 - COMPEX 2

K940301 is an FDA 510(k) clearance for COMPEX 2, manufactured by Biodex Medical Systems, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K940301 · Biodex Medical Systems, Inc. · Physical Medicine device
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Dec 1994
Decision
338d
Days
Class 2
Risk

K940301 is an FDA 510(k) clearance for the COMPEX 2. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Biodex Medical Systems, Inc. (Shirley, US). The FDA issued a Cleared decision on December 28, 1994 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Biodex Medical Systems, Inc. devices

FDA 510(k) Submission Details - K940301

510(k) Number K940301 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 24, 1994
Decision Date December 28, 1994
Days to Decision 338 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 115d · This submission: 338d
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 199
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K940301.
BX-200 SC
K943185 · Bloomex International, Inc. · Aug 1995
CHAL-2500
K946186 · Hogan & Hartson · Aug 1995
DYNATRON 250
K944935 · Dynatronics Corp. · Jun 1995
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
GALVANIC GENERATOR MODEL IMF4150/A
K932916 · Biomedical Life Systems, Inc. · Jan 1994
IF-II (TM), MODEL 7200
K923914 · Medical Devices, Inc. · Nov 1992