BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20

    K Number: K070142 · Decision Mar 23, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    152
    Applicant Total
    5
    Review Days
    66

    Basic Information

    Device Name
    SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20
    K Number
    K070142
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BIO-MEDICAL RESEARCH CORP.
    Date Received
    January 16, 2007
    Decision Date
    March 23, 2007
    Product Code
    NGX
    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
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

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    Other Clearances by BIO-MEDICAL RESEARCH CORP.

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    K840148 BMR-16 CLINIC MUSCLE STIMULATOR