Cleared Traditional

ARTHRITIC HEAT WRAP

K925820 · Conair Corp. · Physical Medicine

Feb 1994

Decision

442d

Days

Class 2

Risk

About This 510(k) Submission

K925820 is an FDA 510(k) clearance for the ARTHRITIC HEAT WRAP, a Pad, Heating, Powered (Class II — Special Controls, product code IRT), submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on February 2, 1994, 442 days after receiving the submission on November 17, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5740.

Submission Details

510(k) Number	K925820 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 1992
Decision Date	February 02, 1994
Days to Decision	442 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement