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Data / Medical devices / Canada / Motion Concepts LP

Motion Concepts LP: FDA-registered device maker in Vaughan Ontario, Canada, 3 510(k) clearances

Motion Concepts LP is registered with the FDA (registration 9615350) in Vaughan Ontario, Canada. It lists 12 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 13, 2019. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
9615350
FEI number
3001045529
Address
505 Cityview Blvd Unit#1, Vaughan Ontario, Canada, L4H 0L8
Owner or operator
Motion Concepts (10047591)
Roles
Exporter to the US, Manufacturer
First device listed
October 8, 2014
Registered through
2026
Brand names listed
Bariatric Power Positioning System (BPPS), Chest Harness Interface, Flotech Cushion, Lap Tray, Modular Power Positioning System, Modular Power Standing System (MPSS), Motion Armrest, Motion Concepts Wheelchair Accessories and more

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 13, 2019K191376Modular Power Standing SystemIPLSubstantially EquivalentMotion Conceptsaccessdata.fda.gov
March 8, 2019K182995Bariatric Power Positioning System (BPPS)ITISubstantially EquivalentMotion Conceptsaccessdata.fda.gov
June 30, 2015K150574Modular Power Positioning SystemITISubstantially EquivalentMotion Conceptsaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
August 28, 201469113Class IITerminatedTRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.Motion Concepts identified that there is a possibility of knee support failure occurring through fatigue of two attachment bolts in the Vertical Position System (TRx Vertical Positioner).accessdata.fda.gov

Compare with other makers

Updated August 13, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.