The following data is part of a premarket notification filed by Emg Technology Co., Ltd. with the FDA for Esg 4-wheel Scooter, Esg-03.
Device ID | K033204 |
510k Number | K033204 |
Device Name: | ESG 4-WHEEL SCOOTER, ESG-03 |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | EMG TECHNOLOGY CO., LTD. NO. 58, FU-CHINU ST. Hsin-chu City, TW 300 |
Contact | Jen Ke-min |
Correspondent | Jen Ke-min EMG TECHNOLOGY CO., LTD. NO. 58, FU-CHINU ST. Hsin-chu City, TW 300 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-10-02 |
Decision Date | 2003-11-12 |
Summary: | summary |