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 K941976
Device Name WHEELCHAIR,MECHANICAL
Applicant
Tone World International
629 Fifth Ave.
Pelham,  NY  10803
Applicant Contact DINA M MOTTOLA
Correspondent
Tone World International
629 Fifth Ave.
Pelham,  NY  10803
Correspondent Contact DINA M MOTTOLA
Regulation Number890.3850
Classification Product Code
IOR  
Date Received04/22/1994
Decision Date 06/13/1994
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
-
-