Cleared Traditional

K904332 - MSTIM-2000 EMS

K904332 is an FDA 510(k) clearance for MSTIM-2000 EMS, manufactured by Oms Medical Supplies, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K904332 · Oms Medical Supplies, Inc. · Physical Medicine device
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May 1991
Decision
222d
Days
Class 2
Risk

K904332 is an FDA 510(k) clearance for the MSTIM-2000 EMS. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Oms Medical Supplies, Inc. (Weymouth, US). The FDA issued a Cleared decision on May 1, 1991 after a review of 222 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 - K904332

510(k) Number K904332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1990
Decision Date May 01, 1991
Days to Decision 222 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 116d · This submission: 222d
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 547
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K904332.
HIGH VOLTAGE PULSED GALVANIC STIMULATION APPLICATI
K910801 · Psychoenergetic Systems, Inc. · Sep 1991
EMS/400
K913272 · Altoona Medical Supply · Aug 1991
UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500
K905107 · Universal Technology Systems, Inc. · Aug 1991
RHEOLOGIC I
K903711 · Advanced Rehabilitative Technology, Inc. · Jan 1991
CHANLLENGE 1010 PATIENT KEY PROGRAM STATION
K903149 · Maximum Performance Technologies, Mpts, Inc. · Nov 1990
OMRON PULSE STIMULATOR MODEL HV-F05
K902255 · Omron Electronics, Inc. · Oct 1990
K904332 · MSTIM-2000 EMS
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