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510(k) K182257

UPnRIDE by Upnride Robotics , Ltd. — Product Code IPL

K182257 is an FDA 510(k) premarket notification submitted by Upnride Robotics , Ltd. for the device "UPnRIDE". The FDA issued a decision of Substantially Equivalent on September 12, 2019. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2019
Date Received
August 21, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Standup
Device Class
Class II
Regulation Number
890.3900
Review Panel
PM
Submission Type

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FDA data resources