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

    Bariatric Power Positioning System (BPPS)

    K Number: K182995 · Decision Mar 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    9
    Review Days
    129

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    Basic Information

    Device Name
    Bariatric Power Positioning System (BPPS)
    K Number
    K182995
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Motion Concepts
    Date Received
    October 30, 2018
    Decision Date
    March 8, 2019
    Product Code
    ITI
    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
    ITI Wheelchair, Powered

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    Other Clearances by Motion Concepts

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    K021264 TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND POWER ELEVATING SEAT
    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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