510(k) K191334

Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 by Matia Robotics (Us), Inc. — Product Code IPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2020
Date Received
May 17, 2019
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