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510(k) Data Aggregation

    K Number
    K060150
    Device Name
    SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM
    Manufacturer
    ANDANTE MEDICAL DEVICES LTD.
    Date Cleared
    2006-02-23

    (34 days)

    Product Code
    IRN
    Regulation Number
    890.5575
    Why did this record match?
    Product Code :

    IRN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartStep™ System/ SmartStep™ Clinic System is intended to sense the amount of weight applied to the planter surface of the foot during rehabilitation. The System alerts the user and/or therapist with alarm when the weight exceeded the pre-selected value. Furthermore, the SmartStep™ System/ SmartStep™ Clinic System is intended to be used in any situation in which therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.
    Device Description
    The SmartStep™ System is a monitoring & biofeedback system for gait. The device is a tool, which is intended to assist the clinicians to accurately assess patients who are undergoing weight bearing restrictions and gait therapy training. The SmartStep™ is used to measure the amount of weight being applied to an affected limb, to teach and promote specific weight bearing skills and to test patient's ability to maintain a weight bearing range. The SmartStep™ system is to be used under the supervision of physician or licensed health care provider such as physiotherapist. The SmartStep™ System is comprised of the following three main subelements: Flexible Insole that is placed in the patient's shoe, acting as a pressure-sensing element. Control Unit, connected to PC Software. PC Software that acts as a patient medical record and patient assessment tool. A Manual Pump is used to inflate the Insole compartments.
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    K Number
    K023161
    Device Name
    SMARTSTEP SYSTEM
    Manufacturer
    ANDANTE MEDICAL DEVICE, LTD.
    Date Cleared
    2002-12-10

    (78 days)

    Product Code
    IRN
    Regulation Number
    890.5575
    Why did this record match?
    Product Code :

    IRN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartStep System is intended to sense the amount of weight applied to the plantar surface of the foot during rehabilitation. The device alerts the user and/or therapist with alarm when the weight exceeded the pre-selected value. Furthermore, the SmartStep System is intended to be used in any situation in which therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.
    Device Description
    The SmartStep System is a biofeedback system for gait training and reeducation. The device is a tool to assist clinicians accurately assess patients who are undergoing weight bearing restrictions and gait therapy training. The SmartStep is used to measure the amount of weight being applied to an affected limb, to teach and promote specific weight bearing skills, and to test patient's ability to maintain a weight bearing rang. A patient's weight bearing status is important to know because it is an indicator of overall progress, and with certain conditions, under-weight bearing or over-weight bearing can lead to complication in the rehabilitation process. The SmartStep system is to be used under the supervision of physician or licensed health care provider such as physiotherapist. The SmartStep system is comprised of three sub elements: Flexible Foot force insole that is placed on the inside of a shoe worn by the patient over a sock. Central Processing Unit (CPU)- the unit is connected to computer software. Computer software that acts as a patient medical record and patient assessment tool.
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    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?
    Product Code :

    IRN

    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
    K962591
    Device Name
    FOOT WEIGHT ALARM
    Manufacturer
    CLEVELAND MEDICAL DEVICES, INC.
    Date Cleared
    1996-12-04

    (155 days)

    Product Code
    IRN
    Regulation Number
    890.5575
    Why did this record match?
    Product Code :

    IRN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Foot Weight Alarm is intended for use in the weight bearing training of patients with various orthopedic and neurological disabilities, such as malunion fracture, amputation, and cerebral vascular accident. The Foot Weight Alarm helps train patients by limiting the amount of force placed on the leg or helping a patient to reach a set amount of force in order to facilitate the return to normal gait pattern,
    Device Description
    The Foot Weight Alarm is a foot shaped insole device to fit inside the patient's shoe to warn the patient when they are putting too little or too much weight on a limited weight bearing foot. It consists of an Insole, a Shoe Pouch which laces to the shoe, a foot unit which fits in the Shoe Pouch and connects to the Insole, a data cable that is used by a health care professional to program the Foot Weight Alarm unit; and Foot Weight Alarm Calibration System used by the health care professional to program the Foot Unit.
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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?
    Product Code :

    IRN

    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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    K Number
    K955034
    Device Name
    FORCEGUARD
    Manufacturer
    IMPACT MONITORS, INC.
    Date Cleared
    1996-04-10

    (160 days)

    Product Code
    IRN
    Regulation Number
    890.5575
    Why did this record match?
    Product Code :

    IRN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ForceGuard is used to sense the amount of weight applied to the plantar surface of the foot. The device alerts the wearer and/or therapist with a repeating tone when the weight exceeds the pre-selected value. ForceGuard will be used on patients who have bone, connective tissue or soft tissue damage who also have been instructed by a physician to limit the weight being placed on a lower limb.
    Device Description
    ForceGuard Model 2090 consists of 3 components; footpad, electronics module, and leg band. The leg band is worn around the patient's ankle. The electronics module attaches to the leg band. The footpad, a flexible, fluid filled chamber, plugs into the electronics module and is worn under the plantar surface of the patient's foot inside suitable footwear. The function of the leg band is to secure the electronics module to the patient's ankle. The function of the footpad is to sense the weight being placed through the patient's lower extremity. The electronics module functions as the user interface, processes information from the footpad and alarms when the weight on the footpad exceeds the selected weight.
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