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 K021995
Device Name ESCAPE CONTROL MODULE
Applicant
Specialty Drives Technologies, Inc.
509 Pleasant Hill Church Rd.
Winder,  GA  30680
Applicant Contact SCOTT KERSEY
Correspondent
Specialty Drives Technologies, Inc.
509 Pleasant Hill Church Rd.
Winder,  GA  30680
Correspondent Contact SCOTT KERSEY
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/18/2002
Decision Date 08/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-