510(k) K111273

FIR HEAT THERAPHY SYSYEMS by Shenzhen Anpan Technology Co., Ltd. — Product Code IRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2011
Date Received
May 4, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Heating, Powered
Device Class
Class II
Regulation Number
890.5740
Review Panel
PM
Submission Type