The following data is part of a premarket notification filed by Taiwan King Strong Co., Ltd. with the FDA for Taiwan King Strong Tc 03 Mechanical Wheelchair.
Device ID | K033031 |
510k Number | K033031 |
Device Name: | TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR |
Classification | Wheelchair, Mechanical |
Applicant | TAIWAN KING STRONG CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
Contact | Jen Ke-min |
Correspondent | Jen Ke-min TAIWAN KING STRONG CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-26 |
Decision Date | 2003-12-02 |