The following data is part of a premarket notification filed by Emg Technology Co., Ltd. with the FDA for Epw Powered Wheelchair, Gp-201.
Device ID | K023148 |
510k Number | K023148 |
Device Name: | EPW POWERED WHEELCHAIR, GP-201 |
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 | 2002-09-20 |
Decision Date | 2003-01-24 |
Summary: | summary |