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510(k) Data Aggregation

    K Number
    K053486
    Device Name
    TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET
    Manufacturer
    Date Cleared
    2006-01-04

    (20 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOFFRICHTER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TREND 200 device is for treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg. These devices are not intended for use with ventilator-dependent patients. The TREND 200 device provides continuous positive airway pressure. The TRENDset PC Software is a program for reading the TREND CPAP device patient compliance data.
    Device Description
    The Hoffrichter TREND 200 device provides mono-level CPAP treatment levels over the clinician settable range of 4 to 18 cmH2O. The TREND 200 CPAP device is modification of the TREND 110 CPAP device which adds the following features: - Real time clock with wake-alarm support. . - Audible tone generator with audible alert functions. . - EEPROM capacity increased to store times of device use (patient compliance . data). - Serial port which can transmit the stored times of device use. . - TRENDset PC software which may be used by the clinician to communicate . TRENDSETT O sollware which may be and print the patient compliance data (times of use). - DC power inlet for alternate power source option. . The TREND 200 CPAP device is provided in a compact lightweight THE TREND 200 OF .. See and utilizes the same form factor and enclosure for Casy bodolae acce, and 16 character LCD display with keys accessones as the 7 (END 170 the user with displayed information about on the operator panel provides the access to menus for soft-start ramp, clinical the treathern (set by doctor, PIN code protected), day/date/wake-alarm, prescription (SCL by doctor) nower supply automatically supply adapts to regional mains voltage (115 to 230 VAC). Standard accessories include treatment tubing with integrated Standard - aoceoonoo - including - including available masks and swivels are specified. As in the TREND 110, TREND 200 treatment pressure is measured as As in the 7AEND 110, 178, 1782AB by means of a measuring tube integrated into the therapy tubing. This maximizes accuracy and control of megrated into the therapy tabing. pressure and accounts for losses due to the therapy delivery circuit. Hoffrichter CPAP devices are prescription use devices, and are not intended for life supporting or life sustaining applications.
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    K Number
    K041035
    Device Name
    HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND
    Manufacturer
    Date Cleared
    2004-06-09

    (49 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOFFRICHTER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TREND 110 device is for treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg. These devices are not intended for use with ventilator-dependent patients. The TREND 110 device provides continuous positive airway pressure. The AquaTREND Humidifier accessory provides humidification of the air delivered to the patient.
    Device Description
    Hoffrichter TREND 110 devices provide mono-level CPAP treatment levels over the clinician settable range of 4 to 18 cmH₂O. The TREND 110 CPAP device is provided in a compact lightweight enclosure for easy bedside use. A 2 x 16 character LCD display with keys on the operator panel provides the user with displayed information about the treatment level as well as access to menus for soft-start ramp, clinical prescription (set by doctor, PIN code protected) and hours of operation. TREND 110's power supply automatically supply adapts to regional mains voltage (115 to 230 VAC). Heated humidification is available by installing the AquaTREND /// heated humidifier accessory. A key with LED indicator permits the user to select the humidification level. Moisture contacting materials in the humidifier and therapy tube meet biocompatibility requirements. Treatment pressure is measured as close as possible to the patient mask Freathern of a measuring tube integrated into the therapy tubing. This maximizes accuracy and control of pressure and minimizes losses due to the therapy delivery circuit. TREND 110 has a user selectable ramp function, which starts with a reduced pressure and gradually increases to the treatment pressure to make it more comfortable to fall asleep. The user can adjust the ramp time in 10 minute increments to 0 (no ramp), 10, 20, or 30 minutes. Standard accessories include treatment tubing with integrated measurement tube and headgear. Commercially available masks and swivels are specified. Hoffrichter CPAP devices are prescription use devices, and are not intended for life supporting or life sustaining applications.
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    K Number
    K014074
    Device Name
    HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION
    Manufacturer
    Date Cleared
    2003-07-23

    (590 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOFFRICHTER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Scalar, Scalar Plus, Vector, and Vector Plus devices are for treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg. These devices are not intended for use with ventilator-dependent patients. The Scalar, Scalar Plus, Vector Plus devices provide continuous positive airway pressure. The Scalar Plus and Vector Plus devices provide humidification of the air delivered to the patient.
    Device Description
    Hoffrichter SCALAR and VECTOR CPAP devices provide mono-level CPAP treatment levels over the clinician settable range of 3 to 18 cmH2O. All devices are constructed on a common platform, including case, mechanical and pneumatic components, operator panel, and electronic control system. A 2 x 16 character display with keys on the operator panel provides the user with displayed information about the treatment level as well as access to menus for time/date, ramp and other functions. VECTOR's power supply automatically supply adapts to regional mains voltage (115 to 230 VAC), whereas SCALAR is set to the region (115 or 230 VAC) by rear panel switch. Models with a Plus designation include integrated heated humidification. An adjustment dial permits the user to select the humidification level. Moisture contacting materials in the breathing circuit meet biocompatibility requirements. Treatment pressure is measured as close as possible to the patient mask by means of a measuring tube integrated into the therapy tubing. This maximizes accuracy and control of pressure and minimizes losses due to the therapy delivery circuit. Hoffrichter CPAP devices have a user selectable ramp function, which starts with a reduced pressure and slowly increases to the treatment pressure to make it more comfortable to fall asleep. The user can adjust the ramp time from 0 to 60 minutes. A mask test may be initiated at the full treatment pressure before the ramp begins to check for mask leaks. Accessories include treatment tubing with integrated measurement tube and headgear. Commercially available masks and swivels are specified. A serially connected remote control device, the MULTI 20, supplied for clinician use during patient tests, emulates operator panel functions. Hoffrichter CPAP devices are prescription use devices, and are not intended for life supporting or life sustaining applications.
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