BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Modular Power Standing System

    K Number: K191376 · Decision Aug 13, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    65
    Applicant Total
    9
    Review Days
    82

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    Basic Information

    Device Name
    Modular Power Standing System
    K Number
    K191376
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3900
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Motion Concepts
    Date Received
    May 23, 2019
    Decision Date
    August 13, 2019
    Product Code
    IPL
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IPL Wheelchair, Standup

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    Other Clearances by Motion Concepts

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    K150574 Modular Power Positioning System
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    K994241 TRX-CG POWER TILT AND RECLINE SYSTEM
    K990544 TRX-CG POWER TILT AND RECLINE SYSTEM
    K981837 TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS
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