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510(k) Data Aggregation

    K Number
    K022494
    Device Name
    HOME CARE JELLY
    Manufacturer
    ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
    Date Cleared
    2002-12-02

    (126 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to be used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.
    Device Description
    Not Found
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    K Number
    K022518
    Device Name
    J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT
    Manufacturer
    ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
    Date Cleared
    2002-12-02

    (125 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    Not Found
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    K Number
    K014126
    Device Name
    SANIDAD HEALTH-UP TENS MP-73725
    Manufacturer
    ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
    Date Cleared
    2002-05-03

    (137 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Specific indications: it is used for the symptomatic relief and management . of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems. - . Clinical settings: should be used under the instruction or prescription by qualified health professionals prior to the applications of the device at home or hospital facilities.
    Device Description
    Not Found
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    K Number
    K011846
    Device Name
    BIOTECH POWERED WHEELCHAIR, C650PW
    Manufacturer
    ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
    Date Cleared
    2002-01-18

    (220 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    Not Found
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