Cleared Traditional

HEAT PACK

K841698 · Maddak, Inc. · Physical Medicine
May 1984
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K841698 is an FDA 510(k) clearance for the HEAT PACK, a Pack, Heat, Moist (Class I — General Controls, product code IMA), submitted by Maddak, Inc. (Walker, US). The FDA issued a Cleared decision on May 10, 1984, 17 days after receiving the submission on April 23, 1984. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5730.

Submission Details

510(k) Number K841698 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 1984
Decision Date May 10, 1984
Days to Decision 17 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