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 K080270
Device Name MANUAL RIGID MOBILITY WHEELCHAIR
Applicant
Freedom Designs, Inc.
2241 Madera Rd.
Simi Valley,  CA  93065
Applicant Contact BOB GARDNER
Correspondent
Freedom Designs, Inc.
2241 Madera Rd.
Simi Valley,  CA  93065
Correspondent Contact BOB GARDNER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/01/2008
Decision Date 04/16/2008
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
-
-