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 K951560
Device Name RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS)
Applicant
Radius Intl., Inc.
Water Gardens Pl. Suite 320
100 E. 15th St.
Fort Worth,  TX  76102
Applicant Contact RICHARD A HAMER
Correspondent
Radius Intl., Inc.
Water Gardens Pl. Suite 320
100 E. 15th St.
Fort Worth,  TX  76102
Correspondent Contact RICHARD A HAMER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received04/05/1995
Decision Date 04/17/1995
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
-
-