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510(k) Data Aggregation

    K Number
    K230385
    Device Name
    Ballancer Platinum (1222)
    Manufacturer
    Mego Afek
    Date Cleared
    2023-04-04

    (49 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mego Afek

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ballancer® Platinum is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied. The Ballancer® Platinum System is indicated for: Simulate kneading and stroking of the tissues by use of an inflatable garment. Temporary increase circulation in the areas which the garment is applied Temporary relief of minor muscle aches and pains
    Device Description
    The Ballancer® Platinum is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied.
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    K Number
    K214053
    Device Name
    Amputee Garment for use with Lympha Press Optimal Plus
    Manufacturer
    Mego Afek AC Ltd.
    Date Cleared
    2022-04-14

    (108 days)

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

    Mego Afek AC Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amputee Garment for use with Lympha Press Optimal Plus is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as: · Primary Ivmphedema · Secondary Ivmphedema - - · Venous insufficiency - Venous stasis ulcers - · Dysfunction of the muscle pump - · Post mastectomy edema - · Edema following trauma and sports issues - · Post immobilization edema - · Reduction of wound healing time - · Reduction of pain and swelling after injury and surgery - · The device may also be beneficial in the management of Lipoedema
    Device Description
    Amputee Garment for use with Lympha Press Optimal Plus
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    K Number
    K190493
    Device Name
    Recovery Pump, 737R (RPX)
    Manufacturer
    Mego Afek AC Ltd.
    Date Cleared
    2019-05-15

    (76 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mego Afek AC Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Recovery Pump is an air compression therapy device intended to provide graduated pressure to compression garments. The Recovery Pump is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. The Recovery Pump simulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    The Recovery Pump is an air compression therapy device intended to provide graduated pressure to compression garments.
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    K Number
    K190015
    Device Name
    Ballancer Gold, 1212
    Manufacturer
    Mego Afek AC Ltd.
    Date Cleared
    2019-03-25

    (81 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mego Afek AC Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ballancer® Gold is a pneumatic massage system intended to provide gradient pressure in areas to which the inflatable garment is applied. The Ballancer Gold is indicated for: - · Simulate kneading and stroking of the tissues by use of an inflatable garment. - · Temporary increase circulation in the areas which the garment is applied - · Temporary relief of minor muscle aches and pains
    Device Description
    Ballancer® Gold, Model 1212 is a pneumatic massage system.
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    K Number
    K182003
    Device Name
    Lympha Press Optimal Plus
    Manufacturer
    Mego Afek AC Ltd.
    Date Cleared
    2019-02-27

    (216 days)

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

    Mego Afek AC Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as: - Primary lymphedema - · Secondary lymphedema - · Venous insufficiency - · Venous stasis ulcers - · Dysfunction of the muscle pump - · Post mastectomy edema - · Edema following trauma and sports issues - · Post immobilization edema - · Reducing wound healing time - · Reduction of pain and swelling after injury and surgery - · The device may also be beneficial in the management of Lipoedema The device is intended for hospital, home, and clinic use.
    Device Description
    Not Found
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    K Number
    K172277
    Device Name
    Phlebo Press DVT Model
    Manufacturer
    Mego Afek AC Ltd.
    Date Cleared
    2017-11-03

    (98 days)

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

    Mego Afek AC Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Phlebo Press DVT Model 760D including compression garments is intended for use by healthcare professionals, and patients who are under medical supervision, in treating conditions such as: - · Prevention of deep vein thrombosis (DVT) in patients who may be susceptible - · Reduction of pain and swelling after injury and surgery - · Enhancement of venous circulation - · Prevention of venous stasis - · Assistance in healing of cutaneous ulcers - · Reducing edema - · Treatment of chronic venous insufficiency The device is intended for hospital, home and clinic use
    Device Description
    Not Found
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    K Number
    K170658
    Device Name
    Lympha Press Optimal Plus
    Manufacturer
    Mego Afek AC Ltd.
    Date Cleared
    2017-05-31

    (89 days)

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

    Mego Afek AC Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as: - Primary lymphedema - Secondary lymphedema - · Venous insufficiency - Venous stasis ulcers - · Dysfunction of the muscle pump - Post mastectomy edema - · Edema following trauma and sports issues - · Post immobilization edema - · Reduction of wound healing time - · Reduction of pain and swelling after injury and surgery - · The device may also be beneficial in the management of Lipoedema The device is intended for hospital, home, and clinic use.
    Device Description
    Lympha Press Optimal Plus Model 912
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    K Number
    K163280
    Device Name
    RP Lite 760R
    Manufacturer
    Mego Afek AC Ltd.
    Date Cleared
    2017-01-27

    (67 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mego Afek AC Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RP Lite 760R is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas in people who are in good health. The RP Lite 760R simulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    Not Found
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    K Number
    K150269
    Device Name
    Ballancer 505 System, Model 1201-AC
    Manufacturer
    Mego Afek AC Ltd.
    Date Cleared
    2015-05-26

    (111 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mego Afek AC Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ballancer 505 is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied. The Ballancer 505 System is indicated for: * Simulating kneading and stroking of the tissues by use of an inflatable garment * Temporary increase circulation in areas which the garment is applied * Temporary relief of minor muscle aches and pains
    Device Description
    Ballancer® 505 System, Model 1201-AC is a pneumatic massage system.
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    K Number
    K142772
    Device Name
    Phlebo Press DVT 603
    Manufacturer
    Mego Afek AC Ltd.
    Date Cleared
    2014-12-16

    (82 days)

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

    Mego Afek AC Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Phlebo Press DVT 603 is intended for use by medical professionals and patients who are under medical supervision, in treating conditions such as: - Prevention of deep vein thrombosis (DVT) in patients who may be susceptible - Reduction of pain and swelling after injury and surgery - Enhancement of venous circulation - Prevention of venous stasis - Assistance in healing of cutaneous ulcers - Reduction of compartmental pressures The device is intended for hospital, home and clinic use
    Device Description
    Not Found
    Ask a Question

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