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

    BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000

    K Number: K052625 · Decision Dec 5, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    73

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    Basic Information

    Device Name
    BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
    K Number
    K052625
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bionicare Medical Technologies, Inc.
    Date Received
    September 23, 2005
    Decision Date
    December 5, 2005
    Product Code
    NYN
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NYN Stimulator, Electrical, Transcutaneous, For Arthritis

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    Other Clearances by Bionicare Medical Technologies, Inc.

    K Number Device Name
    K030332 MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000