Cleared Traditional

K073675 - T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP

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

K073675 · Gaymar Industries, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K073675

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
Combination Product No
PCCP Authorized No
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.

ILO Device Classification - Class 2, Special Controls

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 41
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K073675.
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ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY
K964799 · Ormed GmbH · Aug 1997