MEGO afek Agricultural Cooperative Society Ltd

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- Catalog Number : L4MPH005

Device Description : The PCD Pants Lite - S compression garment fastened around the area to be treate The PCD Pants Lite - S compression garment fastened around the area to be treated. The garment contains overlapping air chambers. These air chambers are filled with air from the console in sequence, applying a compressive massage. Once the entire area has been compressed, the console releases the pressure, and there is a brief pause. Then the process starts over again, and is repeated until the treatment session is complete.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

- Catalog Number : L10004C6-US

Device Description : Ballancer® 505 V2 is a massage system intended for use by people in good health. Ballancer® 505 V2 is a massage system intended for use by people in good health. As noted above, Ballancer® 505 V2 simulates the kneading and stroking action of manual massage by use of an inflatable garment that fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

Device Description : Lympha Press Optimal® Optimized for LymphaPod® is a multi-zone calibrated gradie Lympha Press Optimal® Optimized for LymphaPod® is a multi-zone calibrated gradient pneumatic compression therapy system for treatment of lymphedema, venous insufficiency, venous stasis ulcers, dysfunction of the "muscle pump", lipedema, and edemas caused by trauma and immobility.The Lympha Press Optimal® Optimized for LymphaPod® system consists of:• The console (sometimes called "compressor" or "pump"), which supplies air at regulated pressures to a compression garment that is worn over the area to be treated.• Hoses that transfer the air from the console to each of the chambers in the compression garment.• he LymphaPod® compression garment is fastened around the area to be treated. The LymphaPod® garment contains 40 overlapping air chambers. These air chambers are filled with air from the console in sequence, applying a compressive massage. Once the entire garment has been filled, the console releases the pressure, and there is a brief pause. Then the process starts over again and is repeated until the treatment session is complete.The compress-and-release massage action stimulates lymphatic vessels in the treated area to take up and transport lymphatic fluid. The directional massage action encourages transport of the fluid towards the torso for collection by healthy lymphatics and return to the blood circulation. The directional compressive massage also helps reduce venous edema and stimulates venous return.Note: LymphaPod® is a garment designed for larger patients.The Lympha Press Optimal® Optimized for LymphaPod® has been optimized for use with the LymphaPod® garment and is for use with the LymphaPod® garment only.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Device Description : Lympha Press Optimal® system is a multi-zone calibrated gradient pneumatic compr Lympha Press Optimal® system is a multi-zone calibrated gradient pneumatic compression therapy system for treatment of lymphedema, venous insufficiency, venous stasis ulcers, dysfunction of the "muscle pump", lipedema, and edemas caused by trauma and immobility.The Lympha Press Optimal® system consists of:• The console (sometimes called "compressor" or "pump"), which supplies air at regulated pressures to a compression garment that is worn over the area to be treated.• Hoses that transfer the air from the console to each of the chambers in the compression garment.• The compression garment, which is fastened around the area to be treated. Each garment contains overlapping air chambers. These air chambers are filled with air from the console in sequence, applying a compressive massage. Once the entire area has been compressed, the console releases the pressure, and there is a brief pause. Then the process starts over again and is repeated until the treatment session is complete.The compress-and-release massage action stimulates lymphatic vessels in the treated area to take up and transport lymphatic fluid. The directional massage action encourages transport of the fluid towards the torso for collection by healthy lymphatics and return to the blood circulation. The directional compressive massage also helps reduce venous edema and stimulates venous return.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Device Description : The Phlebo Press® DVT system is a pneumatic compression therapy system used to h The Phlebo Press® DVT system is a pneumatic compression therapy system used to help prevent deep vein thrombosis in patients who may be susceptible. It may also be used to treat conditions as listed in the Indications for Use. The massage action applied by the garments compresses the treated areas to enhance blood flow and reduce stasis. Intermittent and sequential pneumatic compression enhances fibrinolytic activity to reduce the risk of clot formation.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Device Description : The Lympha Press® Optimal Plus system is a multi-zone calibrated gradient pneuma The Lympha Press® Optimal Plus system is a multi-zone calibrated gradient pneumatic compression therapy system for treatment of lymphedema, venous insufficiency, venous stasis ulcers, dysfunction of the "muscle pump", lipedema, and edemas caused by trauma and immobility.The Lympha Press® Optimal Plus system consists of:• The console (sometimes called "compressor" or "pump") supplies air at regulated pressures to a compression garment that is worn over the area to be treated.• Hoses transfer the air from the console to each of the chambers in the compression garment.• The compression garment is fastened around the area to be treated. Each garment contains overlapping air chambers. These air chambers are filled with air from the console in sequence, applying a compressive massage. Once the entire area has been compressed, the console releases the pressure, and there is a brief pause. Then the process starts over again and is repeated until the treatment session is complete.The compress-and-release massage action stimulates lymphatic vessels in the treated area to take up and transport lymphatic fluid. The directional massage action encourages transport of the fluid towards the torso for collection by healthy lymphatics and return to the blood circulation.The directional compressive massage also helps reduce venous edema and stimulates venous return.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Device Description : Ballancer® Gold is a massage system intended for use by people in good health. A Ballancer® Gold is a massage system intended for use by people in good health. As noted above, Ballancer® Gold simulates the kneading and stroking action of manual massage by use of an inflatable garment that fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

- Catalog Number : L10005H2R-US

Device Description : RPX® 2020 is a Massage System intended for use by people in good health. As note RPX® 2020 is a Massage System intended for use by people in good health. As noted above, RPX® 2020 simulates the kneading and stroking action of manual massage by use of an inflatable garment that fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

Device Description : The PCD-51™ system is a sequential pneumatic compression therapy system for trea The PCD-51™ system is a sequential pneumatic compression therapy system for treatment and management of lymphedema, venous insufficiency, venous stasis ulcers and dysfunction of the "muscle pump".The PCD-51™ system consists of:• The console (sometimes called "compressor" or "pump"). It supplies air at regulated pressure to a compression garment that is worn around the area to be treated.• Hoses that transfer the air from the console to each of the chambers in the compression garment.• The compression garment is fastened around the area to be treated. Each garment contains 4 overlapping air chambers. These chambers are filled with air from the console in sequence, applying a compressive massage. Once the entire area has been compressed, the console releases the pressure, and there is a brief pause. Then the process starts over again and is repeated until the treatment session is complete.The compress-and-release massage action of the PCD-51™ system stimulates lymphatic vessels in the treated area to take up and transport lymphatic fluid. The directional massage action encourages transport of the fluid towards the torso for collection by healthy lymphatic vessels and return to the blood circulation. The directional compressive massage also helps reduce venous edema and stimulates venous return.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Device Description : The PCD-52™ system is a multi-zone calibrated gradient pneumatic compression the The PCD-52™ system is a multi-zone calibrated gradient pneumatic compression therapy system for treatment of lymphedema, venous insufficiency, venous stasis ulcers, dysfunction of the "muscle pump", and edemas caused by trauma and immobility.The PCD-52™ system consists of:• The console (sometimes called "compressor" or "pump"), which supplies air at regulated pressures to a compression garment that is worn over the area to be treated.• Hoses that transfer the air from the console to each of the chambers in the compression garment.• The compression garment, which is fastened around the area to be treated. Each garment contains overlapping air chambers. These air chambers are filled with air from the console in sequence, applying a compressive massage. Once the entire area has been compressed, the PCD-52™ console releases the pressure, and there is a brief pause. Then the process starts over again and is repeated until the treatment session is complete.The compress-and-release massage action of the PCD-52™ system stimulates lymphatic vessels in the treated area to take up and transport lymphatic fluid. The directional massage action encourages transport of the fluid towards the torso for collection by healthy lymphatics and return to the blood circulation. The directional compressive massage also helps reduce venous edema and stimulates venous return.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1