The following data is part of a premarket notification filed by Emg Technology Co., Ltd. with the FDA for Middle Wheel Drive Power Chair, Cwd01.
Device ID | K062888 |
510k Number | K062888 |
Device Name: | MIDDLE WHEEL DRIVE POWER CHAIR, CWD01 |
Classification | Wheelchair, Powered |
Applicant | EMG TECHNOLOGY CO., LTD. NO. 58, FU-CHINU ST. Hsin-chu City, TW 300 |
Contact | Ke-min Jen |
Correspondent | Ke-min Jen EMG TECHNOLOGY CO., LTD. NO. 58, FU-CHINU 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 | 2006-09-26 |
Decision Date | 2006-10-24 |
Summary: | summary |