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 K011513
Device Name MP3U, POWER WHEELCHAIR
Applicant
Merits Health Products., Inc.
P.O.Box 150356
Cape Coral,  FL  33915
Applicant Contact WINSTON ANDERSON
Correspondent
Merits Health Products., Inc.
P.O.Box 150356
Cape Coral,  FL  33915
Correspondent Contact WINSTON ANDERSON
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/16/2001
Decision Date 08/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-