Device Classification Name |
Vehicle, Motorized 3-Wheeled
|
510(k) Number |
K033240 |
Device Name |
BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200 |
Applicant |
TUNG KENG ENTERPRISE CO., LTD. |
NO. 58 FU-CHIUN ST. |
HSIN-CHU CITY,
TW
427
|
|
Applicant Contact |
Ke-Min Jen |
Correspondent |
TUNG KENG ENTERPRISE CO., LTD. |
NO. 58 FU-CHIUN ST. |
HSIN-CHU CITY,
TW
427
|
|
Correspondent Contact |
Ke-Min Jen |
Regulation Number | 890.3800
|
Classification Product Code |
|
Date Received | 10/06/2003 |
Decision Date | 12/18/2003 |
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
|
Recalls |
CDRH Recalls
|
|
|