BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VARI-SUPPORT LOW BACK POSTURE PILLOW

    K Number: K821838 · Decision Jul 20, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    279
    Registration Numbers
    280
    Same Product Code
    7
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    VARI-SUPPORT LOW BACK POSTURE PILLOW
    K Number
    K821838
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.6820
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Body Therapeutics, Inc.
    Date Received
    June 22, 1982
    Decision Date
    July 20, 1982
    Product Code
    CCX
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CCX Support, Patient Position

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    Other Clearances by Body Therapeutics, Inc.

    K Number Device Name
    K831582 VARI-SUPPORT NECK POSTURE PILLOW
    K821836 PREGNANCY (W) EDGE
    K821837 VARI-SUPPORT NECK POSTURE PILLOW
    K802442 LOW BACK POSTURE PILLOW