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510(k) Data Aggregation

    K Number
    K991313
    Device Name
    ACCUTRED SHOE
    Manufacturer
    ORTHOPEDIC TECHNOLOGY RESEARCH, INC.
    Date Cleared
    1999-06-23

    (68 days)

    Product Code
    IRN
    Regulation Number
    890.5575
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOPEDIC TECHNOLOGY RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AccuTread™ Shoe System is intended for use as a limb load monitoring device to assist in the rehabilitation of patients with insults to their lower extremities. The AccuTread™ Shoe System is intended to be used in any situation in which a therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.
    Device Description
    Not Found
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    K Number
    K960307
    Device Name
    INDEX SHOE
    Manufacturer
    ORTHOPEDIC TECHNOLOGY RESEARCH, INC.
    Date Cleared
    1996-06-27

    (157 days)

    Product Code
    IRN
    Regulation Number
    890.5575
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOPEDIC TECHNOLOGY RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AccuTread™ Shoe is intended for use as a limb load monitoring device to monitor limited weight bearing during rehabilitation of patients with insults to their lower extremities.
    Device Description
    The AccuTread™ Shoe is a shoe-like enclosure, worn by patients having insults to their lower extremities. The device is intended for use to achieve benefits such as: - protection of the affected extremity during the healing process, . - . ease of mind during initial ambulation, and - documentation of compliance or non-compliance to a prescribed weight ● bearing program. These benefits derive from the patient's ability to know that he/she is not exceeding the correct amount of weight applied to the affected extremity as prescribed by their physician. The complete device consists of the following components: - Shoe Body . - Sensor Unit - Transmitter . - . Receiver
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