The following data is part of a premarket notification filed by Tung Keng Enterprise Co., Ltd. with the FDA for Be-mobile 4-wheeled Electric Scooter, Model Dk S600.
Device ID | K033219 |
510k Number | K033219 |
Device Name: | BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600 |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | TUNG KENG ENTERPRISE CO., LTD. NO. 58 FU-CHIUN ST. Hsin-chu City, TW 427 |
Contact | Jen Ke-min |
Correspondent | Jen Ke-min TUNG KENG ENTERPRISE CO., LTD. NO. 58 FU-CHIUN ST. Hsin-chu City, TW 427 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-10-03 |
Decision Date | 2003-11-12 |
Summary: | summary |