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, Powered
510(k) Number K002580
Device Name PRAIRIE CRUISER
Applicant
Raye'S, Inc.
204 W. 2nd St.
P.O. Box 320
Ellis,  KS  67637
Applicant Contact WILLARD L FRICKEY
Correspondent
Raye'S, Inc.
204 W. 2nd St.
P.O. Box 320
Ellis,  KS  67637
Correspondent Contact WILLARD L FRICKEY
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/18/2000
Decision Date 07/03/2001
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
-
-