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

    CHANLLENGE 1010 PATIENT KEY PROGRAM STATION

    K Number: K903149 · Decision Nov 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    11
    Review Days
    110

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    Basic Information

    Device Name
    CHANLLENGE 1010 PATIENT KEY PROGRAM STATION
    K Number
    K903149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Maximum Performance Technologies, Mpts, Inc.
    Date Received
    July 18, 1990
    Decision Date
    November 5, 1990
    Product Code
    IPF
    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
    IPF Stimulator, Muscle, Powered

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    Other Clearances by Maximum Performance Technologies, Mpts, Inc.

    K Number Device Name
    K903148 CHALLENGE 3000 NEUROLOGICAL BOOSTER
    K904360 CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR
    K902511 CHALLENGE 7010 POWERED MUSCLE STIMULATOR
    K902514 CHALLENGE 5010 POWERED MUSCLE STIMULATOR
    K902513 CHALLENGE 6010 POWERED MUSCLE STIMULATOR
    K902512 CHALLENGE 8000 POWERED MUSCLE STIMULATOR
    K901768 CHALLENGE 5000 POWERED MUSCLE STIMULATOR
    K901769 CHALLENGE 6000 POWERED MUSCLE STIMULATOR
    K901770 CHALLENGE 7000 POWERED MUSCLE STIMULATOR
    K901326 CHALLENGE 20 POWERED MUSCLE STIMULATOR
    Search all 11 clearances from Maximum Performance Technologies, Mpts, Inc. →