BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TE-800 PELVIC FLOOR EXERCISER

    K Number: K945937 · Decision Jul 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    8
    Review Days
    221

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    Basic Information

    Device Name
    TE-800 PELVIC FLOOR EXERCISER
    K Number
    K945937
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1425
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Myo/Kinetic Systems, Inc.
    Date Received
    December 5, 1994
    Decision Date
    July 14, 1995
    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 Myo/Kinetic Systems, Inc.

    K Number Device Name
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    K932611 NEUROMUSCULAR STIMULATOR
    K932764 THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P)
    K932399 THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P)
    K914904 THERAPEUTIC STIMULATOR 2100 (TS-2100)