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 K022518
Device Name J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT
Applicant
Roc Chinese-European Industrial Research Society
2064, Tamarin Dr.,
Columbus,  OH  43235
Applicant Contact SHU-CHEN CHENG
Correspondent
Roc Chinese-European Industrial Research Society
2064, Tamarin Dr.,
Columbus,  OH  43235
Correspondent Contact SHU-CHEN CHENG
Regulation Number890.3800
Classification Product Code
INI  
Date Received07/30/2002
Decision Date 12/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-