The following data is part of a premarket notification filed by Wu's Tech Co., Ltd. with the FDA for Wu's 3-wheeled Neo Scooter, Model Wt-t3e.
Device ID | K062790 |
510k Number | K062790 |
Device Name: | WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | WU'S TECH CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW Roc 300 |
Contact | Ke-min Jen |
Correspondent | Ke-min Jen WU'S TECH CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW Roc 300 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-18 |
Decision Date | 2006-10-11 |
Summary: | summary |