Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Pad, Heating, Powered
510(k) Number K111273
Device Name FIR HEAT THERAPHY SYSYEMS
Applicant
Shenzhen Anpan Technology Co., Ltd.
#44, 2nd Rd., Xiakeng, Tongle
Community, Long Gang Town
Shenzhen,  CN 518116
Applicant Contact WANG TAO
Correspondent
Shenzhen Anpan Technology Co., Ltd.
#44, 2nd Rd., Xiakeng, Tongle
Community, Long Gang Town
Shenzhen,  CN 518116
Correspondent Contact WANG TAO
Regulation Number890.5740
Classification Product Code
IRT  
Subsequent Product Code
ILY  
Date Received05/04/2011
Decision Date 11/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-