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 Vehicle, Motorized 3-Wheeled
510(k) Number K090805
Device Name V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710
Applicant
Pride Mobility Products Corp.
182 Susquehanna Ave.
Exeter,  PA  18643
Applicant Contact THOMAS J SCHAPPERT
Correspondent
Pride Mobility Products Corp.
182 Susquehanna Ave.
Exeter,  PA  18643
Correspondent Contact THOMAS J SCHAPPERT
Regulation Number890.3800
Classification Product Code
INI  
Date Received03/25/2009
Decision Date 04/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-