Cleared Traditional

REUSABLE MOIST HEAT PACK

K791653 · Tru-Eze Mfg. Co., Inc. · Physical Medicine
Sep 1979
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K791653 is an FDA 510(k) clearance for the REUSABLE MOIST HEAT PACK, a Pack, Heat, Moist (Class I — General Controls, product code IMA), submitted by Tru-Eze Mfg. Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1979, 24 days after receiving the submission on August 14, 1979. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5730.

Submission Details

510(k) Number K791653 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 1979
Decision Date September 07, 1979
Days to Decision 24 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IMA — Pack, Heat, Moist
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5730