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 Pack, Hot Or Cold, Reusable
510(k) Number K915876
Device Name HOTPAD
Applicant
Ten Comfort Corp.
P.O. Box 577 Yung-Ho
Taiwan R.O.C.,  CN
Applicant Contact CHARLES WONG
Correspondent
Ten Comfort Corp.
P.O. Box 577 Yung-Ho
Taiwan R.O.C.,  CN
Correspondent Contact CHARLES WONG
Regulation Number890.5700
Classification Product Code
IME  
Date Received12/19/1991
Decision Date 02/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-