Cleared Traditional

FIR HEAT THERAPHY SYSYEMS

K111273 · Shenzhen Anpan Technology Co., Ltd. · Physical Medicine

Nov 2011

Decision

188d

Days

Class 2

Risk

About This 510(k) Submission

K111273 is an FDA 510(k) clearance for the FIR HEAT THERAPHY SYSYEMS, a Pad, Heating, Powered (Class II — Special Controls, product code IRT), submitted by Shenzhen Anpan Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 8, 2011, 188 days after receiving the submission on May 4, 2011. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5740.

Submission Details

510(k) Number	K111273 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 2011
Decision Date	November 08, 2011
Days to Decision	188 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF