Cleared Traditional

SPORTS HEAT WRAP

K915241 · Conair Corp. · Physical Medicine

Dec 1991

Decision

37d

Days

Class 2

Risk

About This 510(k) Submission

K915241 is an FDA 510(k) clearance for the SPORTS 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 December 20, 1991, 37 days after receiving the submission on November 13, 1991. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5740.

Submission Details

510(k) Number	K915241 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 1991
Decision Date	December 20, 1991
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement