Cleared Traditional

STEAM PAK MOIST HEAT

K832803 · Electro-Med Health Industries, Inc. · Physical Medicine
Sep 1983
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K832803 is an FDA 510(k) clearance for the STEAM PAK MOIST HEAT, a Pack, Heat, Moist (Class I — General Controls, product code IMA), submitted by Electro-Med Health Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1983, 33 days after receiving the submission on August 18, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5730.

Submission Details

510(k) Number K832803 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1983
Decision Date September 20, 1983
Days to Decision 33 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