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, Wt-t3d.
Device ID | K032488 |
510k Number | K032488 |
Device Name: | WU'S 3-WHEELED NEO SCOOTER, WT-T3D |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | WU'S TECH CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW Roc 300 |
Contact | Jen Ke-min |
Correspondent | Jen Ke-min 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 | 2003-08-12 |
Decision Date | 2003-12-02 |