Cleared Traditional

INSULATED THERMOELASTOMER MITT

K823622 · Fred Sammons, Inc. · Physical Medicine
Dec 1982
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K823622 is an FDA 510(k) clearance for the INSULATED THERMOELASTOMER MITT, a Pack, Heat, Moist (Class I — General Controls, product code IMA), submitted by Fred Sammons, Inc. (Walker, US). The FDA issued a Cleared decision on December 30, 1982, 24 days after receiving the submission on December 6, 1982. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5730.

Submission Details

510(k) Number K823622 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 1982
Decision Date December 30, 1982
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