BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇾 Malaysia

    Vibrance Pelvic Trainer

    K Number: K162689 · Decision Jun 8, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    2
    Review Days
    254

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    Basic Information

    Device Name
    Vibrance Pelvic Trainer
    K Number
    K162689
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1425
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bioinfinity (M) Sdn. Bhd.
    Date Received
    September 27, 2016
    Decision Date
    June 8, 2017
    Product Code
    HIR
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIR Perineometer

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    Other Clearances by Bioinfinity (M) Sdn. Bhd.

    K Number Device Name
    K141893 VIBRANCE KEGEL DEVICE (VKD)