Cleared Traditional

K073675 - T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP

K073675 is the FDA 510(k) clearance for T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP by Gaymar Industries, Inc.. It is a Class 2 Physical Medicine device (product code ILO) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K073675 · Gaymar Industries, Inc. · Physical Medicine device
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May 2008
Decision
132d
Days
Class 2
Risk

K073675 is an FDA 510(k) clearance for the T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Gaymar Industries, Inc. (Buffalo, US). The FDA issued a Cleared decision on May 8, 2008 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5720 - 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 Gaymar Industries, Inc. devices

Submission Details

510(k) Number K073675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2007
Decision Date May 08, 2008
Days to Decision 132 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
17d slower than avg
Panel avg: 115d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ILO Pack, Hot Or Cold, Water Circulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5720
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 - ILO Pack, Hot Or Cold, Water Circulating

All 16
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K073675.
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