Cleared Traditional

K962195 - HEALTH O METER ELECTRIC HEATING PADS MO...

K962195 is an FDA 510(k) clearance for HEALTH O METER ELECTRIC HEATING PADS MO..., manufactured by Sunbeam Health Division. The device is a Class 2 Physical Medicine device with product code IRT cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K962195 · Sunbeam Health Division · Physical Medicine device
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Nov 1996
Decision
173d
Days
Class 2
Risk

K962195 is an FDA 510(k) clearance for the HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3. Classified as Pad, Heating, Powered (product code IRT), Class II - Special Controls.

Submitted by Sunbeam Health Division (Bridgeview, US). The FDA issued a Cleared decision on November 27, 1996 after a review of 173 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5740 - 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 Sunbeam Health Division devices

FDA 510(k) Submission Details - K962195

510(k) Number K962195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1996
Decision Date November 27, 1996
Days to Decision 173 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 115d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRT Device Classification - Class 2, Special Controls

Product Code IRT Pad, Heating, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5740
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.