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510(k) Data Aggregation

    K Number
    K053510
    Device Name
    IR WIRELESS FOOT SWITCH
    Manufacturer
    LINEMASTER SWITCH CORP.
    Date Cleared
    2006-03-20

    (94 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    LINEMASTER SWITCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Linemaster wireless foot switch is an accessory that is indicated for use to provide foot switch input control to any medical device that uses a wired foot switch with a switch closure (on/off), to activate said device. The system is intended for use in hospitals, outpatient clinics and physicians offices.
    Device Description
    The Linemaster wireless foot switch will be an accessory to and provide foot switch input control to any medical device that uses a foot switch to control on/off inputs. The system includes a wireless foot switch and a receiver. The wireless foot switches share the same transmission schemes, however each manufacturer will have a unique identification code that is programmed into the transmitter and receiver. This identification code will only allow communication of systems that have been programmed with the same identification code. Systems from different manufacturers will not communicate with each other. When coupled with a system that uses a wired foot switch the wireless system will function in the same way as the wired version. Apart from the software, the technological characteristics are the same or similar to, those of the predicate wired device where LED-based systems and infrared signals are used to operate the device. The elimination of wires on the floor of the operating room will improve the safety and efficiency by uncluttering the OR floor and reducing set-up and cleanup time.
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