Cleared Traditional

Heated Eye Pad

K142228 · Digital Heat Corporation · Physical Medicine

Feb 2015

Decision

180d

Days

Class 2

Risk

About This 510(k) Submission

K142228 is an FDA 510(k) clearance for the Heated Eye Pad, a Pad, Heating, Powered (Class II — Special Controls, product code IRT), submitted by Digital Heat Corporation (Tempe, US). The FDA issued a Cleared decision on February 9, 2015, 180 days after receiving the submission on August 13, 2014. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5740.

Submission Details

510(k) Number	K142228 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 2014
Decision Date	February 09, 2015
Days to Decision	180 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement