The following data is part of a premarket notification filed by Freerider Corporation with the FDA for Luggie Chair.
Device ID | K160139 |
510k Number | K160139 |
Device Name: | Luggie Chair |
Classification | Wheelchair, Powered |
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 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-01-21 |
Decision Date | 2017-03-20 |
Summary: | summary |