The following data is part of a premarket notification filed by Taiwan King Strong Co., Ltd. with the FDA for Taiwan King Strong Tc 04 Mechanicalwheelchair.
Device ID | K042652 |
510k Number | K042652 |
Device Name: | TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR |
Classification | Wheelchair, Mechanical |
Applicant | TAIWAN KING STRONG CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
Contact | Ke-men Jen |
Correspondent | Ke-men Jen 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 | 2004-09-28 |
Decision Date | 2004-11-04 |