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510(k) Data Aggregation

    K Number
    K020743
    Device Name
    PADPRO, MODEL 2502
    Manufacturer
    PADPRO LLC.
    Date Cleared
    2002-05-28

    (83 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    PADPRO LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PadPro 2502 Sterile radiotransparent external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, disposable device for single patent use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. Intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).
    Device Description
    The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. PadPro electrodes can be used on all makes and models of defibrillator, including all of the Bi-Phasic units. Radio transparent. "One Pad System" enables the pads to stay with the patient as they move through departments. PadPro has an electrode for any clinical need or patient situation. The high tack adhesive gel allows PadPro electrodes to be repositioned multiple times. PadPro can provide onsite conversion of current cables to accept the PadPro electrodes. The polymer adhesive gel allows superior contact for uniform current distribution and more effective defibrillation and pacing. PadPro's adapter system simply plugs into the OEM cable. Standardization of products - One connector can be used throughout the institution, no matter what brand or model of defibrillation/pacing unit is being used. All PadPro products are Latex free.
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    K Number
    K020203
    Device Name
    PADPRO MODEL #2516
    Manufacturer
    PADPRO LLC.
    Date Cleared
    2002-05-08

    (106 days)

    Product Code
    MKJ, MLN
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    PADPRO LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PadPro Radiotranslucent (minor shadowing) external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patent use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).
    Device Description
    The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. PadPro electrodes can be used on all makes and models of defibrillator, including all of the Bi-Phasic units. Radio transparent. "One Pad System" enables the pads to stay with the patient as they move through departments. PadPro has an electrode for any clinical need or patient situation. The high tack adhesive gel allows PadPro electrodes to be repositioned multiple times. PadPro can provide onsite conversion of current cables to accept the PadPro electrodes. The polymer adhesive gel allows superior contact for uniform current distribution and more effective defibrillation and pacing. PadPro's adapter system simply plugs into the OEM cable. Standardization of products - One connector can be used throughout the institution, no matter what brand or model of defibrillation/pacing unit is being used. All PadPro products are Latex free.
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    K Number
    K020288
    Device Name
    PADPRO, MODEL 2603
    Manufacturer
    PADPRO LLC.
    Date Cleared
    2002-02-27

    (30 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    PADPRO LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PadPro pediatric electrodes are indicated for use in external pacing, defibiliation and monitoring applications as a non-sterne, disposable device for single pediatric use only. The PadPro 2603 electrodes provide ine conductive meetiatic patient's skin. The electrode is intended for use on < pediatric patients whose weight is less than 10kg (22 lbs). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied when a patient requires defibrination, carents . This. device is intended for use on defibrillators whose of specifical fea to the patient and collined to the unstrum. The 2017 pediatric electrodes are designed for, ~ output is can be ininted to bio-control, Zoll, and Hewlett Packard defibrillators.
    Device Description
    The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. PadPro electrodes can be used on all makes and models of defibrillator, including all of the Bi-Phasic units. Radio transparent. "One Pad System" enables the pads to stay with the patient as they move through departments. PadPro has an electrode for any clinical need or patient situation. The high tack adhesive gel allows PadPro electrodes to be repositioned multiple times. PadPro can provide onsite conversion of current cables to accept the PadPro electrodes. The polymer adhesive gel allows superior contact for uniform current distribution and more effective defibrillation and pacing. PadPro's adapter system simply plugs into the OEM cable. Standardization of products - One connector can be used throughout the institution, no matter what brand of defibrillation/pacing unit is being used. All PadPro products are Latex free.
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    K Number
    K014209
    Device Name
    PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS
    Manufacturer
    PADPRO LLC.
    Date Cleared
    2002-01-18

    (28 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    PADPRO LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PadPro radiotransparent external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patent use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).
    Device Description
    The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. PadPro electrodes can be used on all makes and models of defibrillator, including all of the Bi-Phasic units. Radio transparent. "One Pad System" enables the pads to stay with the patient as they move through departments. PadPro has an electrode for any clinical need or patient situation. The high tack adhesive gel allows PadPro electrodes to be repositioned multiple times. PadPro can provide onsite conversion of current cables to accept the PadPro electrodes. The polymer adhesive gel allows superior contact for uniform current distribution and more effective defibrillation and pacing. PadPro's adapter system simply plugs into the OEM cable. Standardization of products - One connector can be used throughout the institution, no matter what brand or model of defibrillation/pacing unit is being used. All PadPro products are Latex free.
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    K Number
    K003548
    Device Name
    PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS
    Manufacturer
    PADPRO LLC.
    Date Cleared
    2001-09-04

    (291 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    PADPRO LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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