The following data is part of a premarket notification filed by Freerider Corporation with the FDA for Luggie Super.
Device ID | K151944 |
510k Number | K151944 |
Device Name: | Luggie Super |
Classification | Vehicle, Motorized 3-wheeled |
Applicant | Freerider Corporation No. 22 Bengong 5th Road Kang-shan Dist, TW 820 |
Contact | Arthur Wang |
Correspondent | Michael Chen Freerider Corporation No. 22 Bengong 5th Road Kang-shan Dist, TW 820 |
Product Code | INI |
CFR Regulation Number | 890.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-14 |
Decision Date | 2015-09-10 |
Summary: | summary |