Ballancer Platinum (1222)
Mego Afek
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9611425 | 3002807566 | MEGO AFEK AC Ltd. | 1 | N | 2026-01-01 | Kibbutz Afek Afek Northern IL 3004200 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07290105870155 | 201Max Calibrated device - "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." | 7327929677 | info@lympha-press.com |
| 07290105870155 | 201Max Calibrated device - "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." | 8885967421 | info@patriotmedical.com |
| 07290105878946 | Lympha Press Optimal 1201AD - "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." | 7327929677 | info@lympha-press.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 41162 | 1804090397 | K254267 | NanoPress 760A-BT (760A-BT) | JOW | 2026-02-24 |
| 41162 | 1217053410 | K230385 | Ballancer Platinum (1222) | IRP | 2023-04-04 |
| 41162 | 1427517930 | K214053 | Amputee Garment for use with Lympha Press Optimal Plus | JOW | 2022-04-14 |
| 41162 | 1787147600 | K190493 | Recovery Pump, 737R (RPX) | IRP | 2019-05-15 |
| 41162 | 2023207061 | K190015 | Ballancer Gold, 1212 | IRP | 2019-03-25 |
| 41162 | 1707303750 | K182003 | Lympha Press Optimal Plus | JOW | 2019-02-27 |
| 41162 | 1281703646 | K172277 | Phlebo Press DVT Model | JOW | 2017-11-03 |
| 41162 | 1836601152 | K170658 | Lympha Press Optimal Plus | JOW | 2017-05-31 |
| 41162 | 1438703240 | K163280 | RP Lite 760R | IRP | 2017-01-27 |
| 41162 | 1760328858 | K150269 | Ballancer 505 System, Model 1201-AC | IRP | 2015-05-26 |
| 41162 | 1590431186 | K142772 | Phlebo Press DVT 603 | JOW | 2014-12-16 |
| 41162 | 1772919722 | K140642 | PCD 737A | JOW | 2014-06-10 |
| 41162 | 1635231182 | K140519 | RECOVERY PUMP 737R | IRP | 2014-06-16 |
| 41162 | 2053500149 | K131420 | PETITE BASIC SYSTEM 701 ELT | JOW | 2013-11-01 |
| 41162 | 1683670158 | K121962 | PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B | JOW | 2012-10-19 |
| 41162 | 1476960193 | K112479 | DSJ MASSAGER | IRP | 2011-12-07 |
| 41162 | 1585684648 | K100677 | LYMPHA PRESS 201MAX, MODEL 201MAX | JOW | 2010-05-20 |
| 41162 | 2024504059 | K100521 | COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS | JOW | 2010-05-14 |
| 41162 | 1178407341 | K082149 | LYMPHA PRESS OPTIMAL, MODEL# 1201AP | JOW | 2008-10-06 |
| 41162 | 1710338485 | K072372 | PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE | JOW | 2007-11-21 |
| 41162 | 1786735239 | K060220 | PBS MODEL 701A COMPRESSION THERAPY DEVICE | JOW | 2006-02-09 |
| 41162 | 1569026088 | K013331 | LYMPHA PRESS PLUS DEVICE | JOW | 2001-11-30 |
| 41162 | 1835712089 |
Mego Afek
Mego Afek AC Ltd.
Mego Afek AC Ltd.
Mego Afek AC Ltd.
Mego Afek AC Ltd.
Mego Afek AC Ltd.
Mego Afek AC Ltd.
Mego Afek AC Ltd.
Mego Afek AC Ltd.
Mego Afek AC Ltd.
MEGO AFEK AC LTD
MEGO AFEK AC LTD
MEGO AFEK AC LTD
MEGO AFEK AC LTD
MEGO AFEK AC LTD
MEGO AFEK AC LTD
MEGO AFEK AC LTD
MEGO AFEK AC LTD
MEGO AFEK
MEGO AFEK
MEGO AFEK
MEGO AFEK
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