Device Description : Lympha Press® 201Max™ is a calibrated gradient pneumatic compression therapy sys Lympha Press® 201Max™ is a calibrated gradient pneumatic compression therapy system for treatment of lymphedema, venous insufficiency, venous stasis ulcers and dysfunction of the "muscle pump".The Lympha Press® 201Max™ system consists of:• The console (sometimes called "compressor" or "pump"), supplying air at fixed 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 cells in the compression garment.• The compression garment (sometimes called a "sleeve"), fastened around the area to be treated. Each garment contains up to 24 overlapping air cells. These air cells are filled with air from the console in sequence, applying a compressive massage. Once the entire limb has been compressed, Lympha Press® 201Max™ 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 Lympha Press® 201Max™ 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
Prescription Use : Yes
Device Description : Ballancer® 505 is a massage system intended for use by people in good health. As Ballancer® 505 is a massage system intended for use by people in good health. As noted above, Ballancer® 505 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
Prescription Use : No
Device Description : The NanoPress™ system is a sequential pneumatic compression therapy system for t The NanoPress™ 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 NanoPress™ 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 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 NanoPress™ 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
Prescription Use : Yes
Device Description : RP Lite® is a massage system intended for use by people in good health.As noted RP Lite® is a massage system intended for use by people in good health.As noted above, RP Lite® 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
Prescription Use : No
Device Description : The #4 Adult Boot XL (4 cells) compression garment fastened around the area to b The #4 Adult Boot XL (4 cells) 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
Prescription Use : Yes
Device Description : The Adult Boot # 1A RC-FLS compression garment fastened around the area to be tr The Adult Boot # 1A RC-FLS 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
Prescription Use : Yes
Device Description : The Adult boot No. 2A RC-FLS compression garment fastened around the area to be The Adult boot No. 2A RC-FLS 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
Prescription Use : Yes
Device Description : The FL sleeve 2-75 RC-FLS compression garment fastened around the area to be tre The FL sleeve 2-75 RC-FLS 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
Prescription Use : Yes
Device Description : The FL sleeve 2-85 RC-FLS compression garment fastened around the area to be tre The FL sleeve 2-85 RC-FLS 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
Prescription Use : Yes
Device Description : The FL sleeve 3-85 RC-FLS compression garment fastened around the area to be tre The FL sleeve 3-85 RC-FLS 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
Prescription Use : Yes