Cleared Traditional

K902255 - OMRON PULSE STIMULATOR MODEL HV-F05

K902255 is the FDA 510(k) clearance for OMRON PULSE STIMULATOR MODEL HV-F05 by Omron Electronics, Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K902255 · Omron Electronics, Inc. · Physical Medicine device
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Oct 1990
Decision
163d
Days
Class 2
Risk

K902255 is an FDA 510(k) clearance for the OMRON PULSE STIMULATOR MODEL HV-F05. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Omron Electronics, Inc. (Washington, US). The FDA issued a Cleared decision on October 31, 1990 after a review of 163 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.

View all Omron Electronics, Inc. devices

Submission Details

510(k) Number K902255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1990
Decision Date October 31, 1990
Days to Decision 163 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
48d slower than avg
Panel avg: 115d · This submission: 163d
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 135
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K902255.
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