The following data is part of a premarket notification filed by Kwang Yang Motor Co., Ltd. with the FDA for Kymco Eq10d Scooter.
Device ID | K163201 |
510k Number | K163201 |
Device Name: | KYMCO EQ10D Scooter |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | KWANG YANG MOTOR CO., LTD. No. 35, Wan Hsing Street, San Min Dist. Kaohsiung, TW 803 |
Contact | Wang Ching Yun |
Correspondent | Junnata Chang Mrs. Junnata Chang 16F-2(16A), No. 462, Sec. 2, ChongDe Rd., Beitun Dist. Taichung, TW 406 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-15 |
Decision Date | 2017-03-16 |
Summary: | summary |