Cleared Traditional

T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP

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

About This 510(k) Submission

K073675 is an FDA 510(k) clearance for the T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP, a Pack, Hot Or Cold, Water Circulating (Class II — Special Controls, product code ILO), submitted by Gaymar Industries, Inc. (Buffalo, US). The FDA issued a Cleared decision on May 8, 2008, 132 days after receiving the submission on December 28, 2007. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5720.

Submission Details

510(k) Number K073675 FDA.gov
FDA Decision Cleared 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

Device Classification

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