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510(k) Data Aggregation

    K Number
    K243339
    Device Name
    WiTOF
    Manufacturer
    IDMED
    Date Cleared
    2025-06-23

    (241 days)

    Product Code
    KOI
    Regulation Number
    868.2775
    Why did this record match?
    Applicant Name (Manufacturer) :

    IDMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WiTOF is a neuromuscular transmission station (nerve stimulator) that helps to pilot the neuromuscular blockade of adult patients in the operating room, recovery room or intensive care unit.
    Device Description
    The WiTOF is a neuromuscular transmission station (nerve stimulator) that helps to pilot the neuromuscular blockade of adult patients in the operating room, recovery room or intensive care unit. It is used by health professionals (anaesthesiologists, doctors, or fully qualified nurse anaesthetists) for: 1. Objective neuromuscular transmission monitoring 2. Subjective neuromuscular transmission monitoring The continuous monitoring of NMT blocking involves electrical nerve stimulation and the measurement of acceleration in the corresponding muscle (with a three-dimensional acceleration sensor). Based on the force of contraction resulting from the stimulation, it is possible to draw conclusions about the effectiveness of an injected neuromuscular blocking agents or the patient's curare level. The device and all of the settings associated with it are designed for use on adult patients in hospital or health institutions so that the patient's curare level can be monitored. The WiTOF system is composed of the station, the wireless sensor (hand), and the US AC power supply unit. The wireless sensor itself consists of the 3D accelerometer in the splint. The WiTOF can perform several different modes of electrical stimulation in accordance with usual clinical practice: - TOF (Train Of Four) - PTC (Post Tetanic Count) - ATP (Automated TOF PTC) - DBS (Double Burst) (3,3) (3,2) - ST (Single Twitch) 0.1 Hz and 1 Hz - TET (Tetanus) 50 Hz and 100 Hz The station displays the various stimulation settings, the time elapsed between stimulations, and the results for the measurements made in response to TOF, PTC, and ATP stimulations. The responses to other types of stimulation are gaged visually by the health professional. The device and stimulation settings are chosen using a display screen. The accessories that can be used with the device include: - Optic-serial (RS232) cable to transfer data - Fixation clamp – regular size (10–40 mm / 0.4–1.6 inches) - Fixation clamp – large size (20–60 mm / 0.8–2.4 inches)
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    K Number
    K172690
    Device Name
    ToFscan
    Manufacturer
    Idmed
    Date Cleared
    2018-05-31

    (267 days)

    Product Code
    KOI
    Regulation Number
    868.2775
    Why did this record match?
    Applicant Name (Manufacturer) :

    Idmed

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ToFscan is a neuromuscular transmission monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.
    Device Description
    The ToFscan is a neuromuscular transmission (NMT) monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit. It is used by health professionals (anaesthesiologists, doctors, or fully qualified nurse anaesthetists) for: - 1. Objective neuromuscular transmission monitoring - 2. Subjective neuromuscular transmission monitoring The continuous monitoring of NMT blocking involves the stimulation of the ulnar nerve and the corresponding measurement of acceleration in the adductor muscle of the thumb (with a three-dimensional acceleration sensor). Based on the force of contraction resulting from the stimulation, it is possible to draw conclusions about the effectiveness of an injected neuromuscular blocking agents or the patient's curare level. The apparatus and all of the settings associated with it are designed for use on adult and paediatric patients in hospital or health institutions so that the patient's curare level can be monitored. The ToFscan system is composed of the monitor, the hand sensor, and the US AC power supply unit. The hand sensor itself consists of the thumb splint/3D accelerometer, the electrode clamps, and the cable which connects to the monitor. The ToFscan can perform several different modes of electrical stimulation in accordance with usual clinical practice: - -TOF (Train Of Four) - PTC (Post Tetanic Count) - - -ATP (Automated TOF PTC) - DBS (Double Burst) (3,3) (3,2) - - ST (Single Twitch) 0.1 Hz and 1 Hz - - -TET (Tetanus) 50 Hz The monitor displays the various stimulation settings, the time elansed between stimulations, and the results for the measurements made in response to TOF, PTC, and ATP stimulations. The responses to other types of stimulation are gaged visually by the health professional. The device and stimulation settings are chosen using a rotary knob.
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