The following data is part of a premarket notification filed by Foryou Technology Co., Ltd. with the FDA for Foryou Powered Wheelchair, Model Fc-100.
Device ID | K061693 |
510k Number | K061693 |
Device Name: | FORYOU POWERED WHEELCHAIR, MODEL FC-100 |
Classification | Wheelchair, Powered |
Applicant | FORYOU TECHNOLOGY CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
Contact | Ke-min Jen |
Correspondent | Ke-min Jen FORYOU TECHNOLOGY CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-15 |
Decision Date | 2006-07-06 |