• 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 K920180
Device Name QUICKIE P100
Applicant
Sunrise Medical Quickie Designs, Inc.
2842 Business Park Ave.
Fresno,  CA  93727
Applicant Contact PAT SPINK
Correspondent
Sunrise Medical Quickie Designs, Inc.
2842 Business Park Ave.
Fresno,  CA  93727
Correspondent Contact PAT SPINK
Regulation Number890.3860
Classification Product Code
ITI  
Date Received01/14/1992
Decision Date 03/02/1992
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
-
-