The following data is part of a premarket notification filed by Taiwan King Strong Co., Ltd. with the FDA for Taiwan King Strong Powered Wheelchair, Tp 01.
Device ID | K033100 |
510k Number | K033100 |
Device Name: | TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01 |
Classification | Wheelchair, Powered |
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 | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-29 |
Decision Date | 2003-12-02 |
Summary: | summary |