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 Wheelchair, Mechanical
510(k) Number K993298
Device Name E Z CHAIR
Applicant
Premier Designs
4834 W. Jacquelyn, Suite 101
Fresno,  CA  93722
Applicant Contact CHRIS BERRYHILL
Correspondent
Premier Designs
4834 W. Jacquelyn, Suite 101
Fresno,  CA  93722
Correspondent Contact CHRIS BERRYHILL
Regulation Number890.3850
Classification Product Code
IOR  
Date Received10/01/1999
Decision Date 11/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-