The following data is part of a premarket notification filed by Wu's Tech Co., Ltd. with the FDA for Wu's 4-wheeled Neo Scooter, Model Wt-t4d.
| Device ID | K040968 |
| 510k Number | K040968 |
| Device Name: | WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | WU'S TECH CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen WU'S TECH CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-14 |
| Decision Date | 2004-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815027011386 | K040968 | 000 |