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 K021145
Device Name ACCOMMODATOR WHEELCHAIR, MODEL #2000X
Applicant
MARKEN INTERNATIONAL, INC.
851 BRIDGER STR.
SUITE 1
BOZEMAN,  MT  59715
Applicant Contact STEVE RIFFEL
Correspondent
MARKEN INTERNATIONAL, INC.
851 BRIDGER STR.
SUITE 1
BOZEMAN,  MT  59715
Correspondent Contact STEVE RIFFEL
Regulation Number890.3850
Classification Product Code
IOR  
Date Received04/09/2002
Decision Date 05/16/2002
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
-
-