The following data is part of a premarket notification filed by Upnride Robotics Ltd. with the FDA for Upnride.
Device ID | K182257 |
510k Number | K182257 |
Device Name: | UPnRIDE |
Classification | Wheelchair, Standup |
Applicant | UPnRIDE Robotics Ltd. Kochav Yokneam Bld. Yokneam, IL 2069204 |
Contact | Yoram Levy |
Correspondent | Yoram Levy Qsite 31 Haavoda St. Binyamina, IL 30500 |
Product Code | IPL |
CFR Regulation Number | 890.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-08-21 |
Decision Date | 2019-09-12 |
Summary: | summary |