The following data is part of a premarket notification filed by Wu's Tech Co., Ltd. with the FDA for Wu's Powered Wheelchair, Mambo 36x.
| Device ID | K050010 |
| 510k Number | K050010 |
| Device Name: | WU'S POWERED WHEELCHAIR, MAMBO 36X |
| Classification | Wheelchair, Powered |
| 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 | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-03 |
| Decision Date | 2005-02-11 |
| Summary: | summary |