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510(k) Data Aggregation

    K Number
    K213577
    Device Name
    VenAir, Sequential Compression System
    Manufacturer
    Apex Medical Corp.
    Date Cleared
    2022-06-28

    (230 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Apex Medical Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the VenAir Sequential Compression System (hereby referenced as "VenAir system") is to help prevent Deep Vein Thrombosis (DVT) and pulmonary embolism. The garments are single patient use - do not reuse. The VenAir system is intended for use only in professional healthcare facility environment by trained medical staff. It is not for use in the home healthcare environment. The VenAir system should be used as part of a prescribed plan of care.
    Device Description
    The VenAir Sequential Compression System is a sequential pneumatic compression system by applying sequential and gradient pressure to increase venous blood flow and circulation in at-risk patients to help prevent deep vein thrombosis and pulmonary embolism. The product consists of the machine, tubing sets, and disposable (single patient use) garments (thigh, calf, and foot optional purchase) and focuses on compressing the limbs to enhance better blood circulation. The system has digital sensors to check the garment connections, pressure output and power supply. On the other hand, operator can follow the user manual to check the error code and action as advised.
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    K Number
    K193206
    Device Name
    WiZARD 510 Nasal Mask
    Manufacturer
    Apex Medical Corp.
    Date Cleared
    2020-10-29

    (344 days)

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

    Apex Medical Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WIZARD 510 Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The nasal mask is intended for single-patient reuse in the home and multi-use in the hospital environment. The nasal mask is to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bilevel system) has been prescribed.
    Device Description
    The WiZARD 510 Nasal Mask provides an interface to direct airflow from a positive pressure source to the patient's nostril. The mask is held in place with adjustable headgear that straps the mask to the face. The elbow connector is designed with a series of vent holes to exhale air from the mask. WiZARD 510 nasal mask is connected to a CPAP or bi-level system via a standard 22 mm breathing tube. A quick release mechanism allows users to quickly remove the mask from the face. WiZARD 510 Nasal Mask is safe when used under the conditions and purposes as indicated in the labeling provided with the product. WiZARD 510 Nasal Mask is a prescription device supplied in non-sterile condition.
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    K Number
    K182394
    Device Name
    WiZARD 310/320 Series CPAP Mask
    Manufacturer
    Apex Medical Corp.
    Date Cleared
    2019-05-17

    (255 days)

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

    Apex Medical Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WIZARD 310/320 series CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. These masks are intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. These masks are to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.
    Device Description
    The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask provide an interface such that airflow from a positive pressure source is directed to the patient's nostril and mouth. The masks are held in place with adjustable headgear that straps the mask to the face. Series of vent are feature on the cushion that serves as an exhalation vent to purge the exhaled carbon dioxide from the mask. Air coming out from these holes is very diffuse and quiet. WiZARD 310/320 series CPAP mask are connected to the CPAP or bi-level system via standard 22 mm breathing tubing. A quickly-release mechanism also includes which allow the mask can be removed quickly. The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask are appropriate when used under the conditions and purposes intended as indicated in the labeling provided with the product. The WiZARD 310 Nasal Mask and WiZARD 320 Full Face Mask are the prescription device supplied non-sterile.
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    K Number
    K150111
    Device Name
    Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2015-09-15

    (238 days)

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

    APEX MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for single patient reuse in the home environment.
    Device Description
    The modified iCH CPAP with PVA 9S-007XXX Series is a modification of predicate iCH CPAP with PVA 9S-007XXX (K141522). It changed the material of impeller as well as PCB layout compare to the predicate device. A built-in heated humidifier of iCH CPAP with PVA 9S-007XXX Series is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat resulting from constant airflow that some patients may experience.
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    K Number
    K141522
    Device Name
    APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2014-10-06

    (119 days)

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

    APEX MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for single patient reuse in the home environment.
    Device Description
    The iCH CPAP with PVA 9S-007XXX Series are intended to provide continuous positive airway pressure for the treatment of adult obstructive sleep apnea (OSA). It is a modification of iCH CPAP 9S-007XXX (K120035) with the same algorithm of XT Auto with PVA 9S-005720 (K112079). It shares the same construction and auto adjustment algorithm with iCH CPAP 9S-007XXX but adds the identical Pressure Variation Algorithm with the predicate device XT Auto with PVA 9S-005720 (K112079). The Pressure Variation Algorithm provides a release pressure during expiration phase which is designed for patients who have difficulty exhaling against high CPAP pressure. It works by reducing the CPAP setting pressure in the normal breath status of expiratory phase from the treatment pressure in either CPAP or APAP mode. A built-in heated humidifier of iCH CPAP with PVA 9S-007XXX Series are designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat resulting from constant airflow that some patients may experience. The modified iCH CPAP series (with PVA) are from the iCH CPAP 9S-007XXX (K120035), but the algorithm for pressure variation algorithm(PVA) of the device comes from XT Auto with PVA (K112079). The PVA Pressure Variation Alqorithm for the subject and predicated device (K112079) is an exhalation pressure relief function which is designed for patients who have difficulty exhaling against high CPAP pressure. Pressure can be reduced to three different levels (according to patient need) during the transition from Inspiration to Expiration phase. This reduced pressure level (depending on the PVA setting) will be maintained during Expiration phase and will return to the therapeutic pressure in the end of Expiration phase. In order to ensure the effectiveness of CPAP therapy, PVA will be automatically suspended if apneas are detected. After apneas disappear, PVA will re-start.
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    K Number
    K121642
    Device Name
    WIZARD 230 NASAL PILOW MASK
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2013-06-06

    (367 days)

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

    APEX MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WiZARD 230 Nasal Pillow Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. This mask only can be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.
    Device Description
    The WiZARD 230 Nasal Pillow Mask provides an interface such that airflow from a positive pressure source is directed to the patient's nostril. The mask is held in place with adjustable headgear that straps the mask to the face. WiZARD 230 Nasal Pillow Mask is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. WiZARD 230 Nasal Pillow Mask is a prescription device supplied nonsterile.
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    K Number
    K112079
    Device Name
    APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2012-12-06

    (504 days)

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

    APEX MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for use in the home or hospital/institutional environment.
    Device Description
    XT Auto CPAP with Pressure Variation Algorithm Model 9S-005720 is intended to be used to deriving continuous positive airway pressure (CPAP) for Obstructive Sleep Apnea (OSA) in adult patients and home environment. It is a modification of XT Auto CPAP Model 9S-005200(K083656). It shares the same construction and auto adjustment algorithm with XT Auto CPAP but adds expiration pressure release with three constant levels in firmware and has the same downloading function as XT Auto CPAP. XT Auto CPAP with Pressure Variation Algorithm provides a release pressure during expiration phase; it is equivalent to Expiratory Pressure Relief (EPR) of the predicate device RESMED S8 ADVANCE (K082979).
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    K Number
    K120035
    Device Name
    APEX MEDICAL ICH CPAP SERIES (9S-007XXX)
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2012-05-16

    (133 days)

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

    APEX MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA) for adult patients in the home environment.
    Device Description
    9S-007XXX series are intended to provide continuous positive airway pressure for the treatment of adult obstructive sleep apnea (OSA) in home care environment. A built-in heated humidifier of 9S-007xxx series is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat resulting from constant airflow that some patients may experience.
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    K Number
    K103174
    Device Name
    APEX MEDICAL WIZARD SERIES CPAP MASK
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2011-05-06

    (191 days)

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

    APEX MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WiZARD 210/220 series CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. These masks are intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. These masks are to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.
    Device Description
    WiZARD series mask consists of a frame with a cushion seal on the face. Different height forehead support pad are offer to user allow fitting forehead better. Series of vents are feature on the elbow that serves as an exhalation vent to purge the exhaled carbon dioxide from the mask. Air coming out from these holes is very diffuse and quiet. There is no whistling or whooshing sound from the exhalation vent and no jet of air blowing on the bed partner. WiZARD serous mask is connected to the CPAP or bi-level system via standard 22 mm breathing tubing. A quickly-release mechanism also includes which allow the mask can be removed quickly
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    K Number
    K103535
    Device Name
    VACPLUS SUCTION UNIT
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2011-02-24

    (85 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    APEX MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is to be used to remove fluids from the treated tracheotomy patient airway.
    Device Description
    VacPlus is the portable AC/DC powered suction unit. Each one consists of an on/off switch, a pump unit, a non detachable flexible power cord, collection jar, relief valve, pressure gauge, pressure adjustment knob, bacteria filter, suction tubing.
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