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510(k) K150548

Tek RMD (Tek Robotic Mobilization Device) by Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S — Product Code IPL

K150548 is an FDA 510(k) premarket notification submitted by Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S for the device "Tek RMD (Tek Robotic Mobilization Device)". The FDA issued a decision of Substantially Equivalent on June 11, 2015. 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
June 11, 2015
Date Received
March 3, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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  • K172384 — Quickie(r) Q700-UP M (January 16, 2018)
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FDA data resources