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 3.
Device ID | K030707 |
510k Number | K030707 |
Device Name: | WU'S POWERED WHEELCHAIR, MAMBO 3 |
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 | 2003-03-06 |
Decision Date | 2003-04-04 |