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510(k) Data Aggregation

    K Number
    K040718
    Device Name
    TRUST
    Manufacturer
    DHD HEALTHCARE CORP.
    Date Cleared
    2004-04-02

    (14 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    DHD HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1 - Intended Use: The DHD TRUST is intended for use as a nebulizer. - 2 Indications: - The DHD TRUST provides additional hydration to help loosen secretions for patients whom extended therapy is required. - The DHD TRUST delivers aerosolized medications and diagnostic formulations. - 3 Target Patient Population Patients with asthma, pneumonia, COPD, or any other condition in which appropriate medications would be nebulized.
    Device Description
    The DHD TRUST is indicated for use as a single patient use nebulizer. TRUST is a small plastic device that threads onto a regulated flow meter supplying air or oxygen. A reservoir bottle threads to the bottom of TRUST to hold water and/or medication. Trust has a secondary port on the side of the device to allow for supplemental air, oxygen, or heliox.
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    K Number
    K002768
    Device Name
    ACAPELLA
    Manufacturer
    DHD HEALTHCARE CORP.
    Date Cleared
    2000-12-05

    (90 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    DHD HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003146
    Device Name
    CLINIFLO INCENTIVE SPIROMETER
    Manufacturer
    DHD HEALTHCARE CORP.
    Date Cleared
    2000-11-21

    (42 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    DHD HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991561
    Device Name
    ROADRUNNER, PEP THERAPY DEVICE
    Manufacturer
    DHD HEALTHCARE CORP.
    Date Cleared
    1999-11-10

    (190 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    DHD HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DHD Roadrunner is indicated for use as a Positive Expiratory Pressure (PEP) Device. Claims: - The use of DHD Roadrunner improves clearance of secretions - The use of DHD Roadrunner may reduce the need for postural drainage - DHD Roadrunner facilitates opening of airways in patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems - The DHD Roadrunner may be used to prevent or reverse atelectasis
    Device Description
    The DHD Roadrunner is indicated for use as a single patient use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when a patient exhales through the device.
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    K Number
    K991300
    Device Name
    BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE
    Manufacturer
    DHD HEALTHCARE CORP.
    Date Cleared
    1999-07-12

    (87 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    DHD HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Boeing is indicated for the treatment and prevention of atelectasis. Boeing facilitates opening of airways in patients requiring prevention or treatment of atelectasis. Boeing also has the ability to provide supplemental oxygen when used with compressed oxygen.
    Device Description
    The DHD Boeing is a single-patient-use Respiratory Therapy device. The standard system consists of a flow amplification body, compressed oxygen/air tubing, pressure port cap, and mouthpiece. The mouthpiece can be replaced with a mask.
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    K Number
    K983467
    Device Name
    THERAPEP
    Manufacturer
    DHD HEALTHCARE CORP.
    Date Cleared
    1999-04-02

    (189 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    DHD HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DHD TheraPEP® is intended for use as a Positive Expiratory Pressure Device for patients suffering from Cystic Fibrosis, lung diseases with secretory problems, and to prevent or reverse atelectasis. The device may be used in conjuction with aerosol drug therapy. The DHD TheraPEP is intended for use as a Positive Expiratory Pressure (PEP) device. It may also be used simultaneously with aerosol drug delivery using a nebulizer or Metered Dose Inhaler (MDI) with spacer.
    Device Description
    The DHD TheraPEP® is a single-patient-use Respiratory Therapy device. The standard system consists of a resistor, pressure range indicator, pressure port adapter, and mouthpiece. The mask may be substituted for the mouthpiece. Pressure monitoring is optional, and the pressure port adapter is removable. Air and aerosolized drugs are drawn in through the inlet of TheraPEP, which is opposite the mouthpiece end of the device. The air and aerosolized drug passes by the inlet valve which baffles out some of the medication, primarily large diameter particles of aerosolized drug which can not be absorbed by the patient's lung tissue. The air and respirable diameter particles of the aerosolized drug continue undeterred past the inlet device and through the device past the mouthpiece and into the patient's body. As the user begins exhaling, the inlet valve closes, forcing all of the air from the lungs out the selected orifice in the selector dial. The MDI with spacer or Nebulizer may be connected directly or by means of an adapter to the 22mm O.D. inlet end (opposite mouthpiece end) of the TheraPEP device. Positive Expiratory Pressure (PEP) occurs during exhalation and aerosol drug delivery occurs during inspiration. Use of an MDI Spacer and/or Nebulizer requires the same technique of breathing for inhalation and breath hold as does PEP therapy. A patient would be instructed by a clinician to take in a larger than normal breath for PEP Therapy or Aerosol Drug delivery followed by a short breath hold prior to exhalation. PEP occurs during exhalation and helps prolong exhalation plus keeps airways open longer thereby helping to move secretions, increase the transpulmonary pressure gradient, and resolve atelectasis.
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    K Number
    K980662
    Device Name
    LICHEN, BACTERIAL IN LINE BREATHING FILTER
    Manufacturer
    DHD HEALTHCARE CORP.
    Date Cleared
    1998-09-14

    (206 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    DHD HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DHD Healthcare Lichen Filter Kit is intended to filter airborne particulate matter and certain bacteria (i.e., Staphylococcus) with a mean diameter of 3.2 microns or greater. The Lichen may reduce cross-contamination between patient and equipment attachments such as use with Respiratory Therapy low flow pressure indicators and gauges (i.e., an example would be for use with the DHD TheraPEP® Pressure Indicator and aneroid gauges). The use of the Lichen Filter Kit may allow the reuse of aneroid gauges and pressure indicators from patient to patient per your institution's protocol. The device also incorporates tubing for use in connection to low flow pressure indicators and gauges.
    Device Description
    The DHD Lichen Product is a kit consisting of a hydrophobic bi-directional filter with tubing that is connected to each side of the hydrophobic bi-directional filter. This assembled filter kit is a single-patient-use device intended for infection control for use with low flow pressure indicators and both inspiratory and expiratory maneuvers with low flow pressure indicators and gauges where the patient exhales at a pressure of less than 120cm H20.
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    K Number
    K981167
    Device Name
    STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT
    Manufacturer
    DHD HEALTHCARE CORP.
    Date Cleared
    1998-06-18

    (78 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    DHD HEALTHCARE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DHD Stealth Metered Dose Inhaler (MDI) Spacer (Without Integral Actuator) assists with the delivery of aerosolized medications when used in conjunction with commercially available Metered Dose Inhaler (MDI) canisters with their associated actuator elbows. In addition, for convenience, the MDI canister/elbow, may be stored inside of the Stealth when not in use (the spacer acts as the MDI canister/elbow holding chamber). Pilot is a one piece, silicone rubber face mask that may be attached to the Stealth MDI holding chamber as an interface between the Stealth MDI and the patient's face/mouth region.
    Device Description
    The Pilot device is a mask attachment for the Stealth Metered Dose Inhaler (MDI) Spacer. The Pilot mask fits directly onto the Stealth MDI Spacer. Pilot is a single piece, injection molded, silicone rubber piece. It is intended for single patient use and may be disassembled from the Stealth MDI for convenient cleaning the device, by hand, in warm soapy water. The Pilot mask will be available in several sizes. and large masks. The mask sizes are designed to fit comfortably to a users face. The masks also include a tapered fitting designed to mate with the Stealth mouthpiece. The tapered fitting includes a small ledge which serves as a stop, preventing the mask from being advanced too far onto the Stealth mouthpiece.
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