201Max Calibrated device L1000063

GUDID 07290105870155

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.

MEGO afek Agricultural Cooperative Society Ltd

Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump
Primary Device ID07290105870155
NIH Device Record Key0b03a81e-2bbe-4304-9103-2eb8c0fd80dd
Commercial Distribution Discontinuation2023-06-14
Commercial Distribution StatusNot in Commercial Distribution
Brand Name201Max Calibrated device
Version Model Number201Max
Catalog NumberL1000063
Company DUNS514658082
Company NameMEGO afek Agricultural Cooperative Society Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7327929677
Emailinfo@lympha-press.com
Phone7327929677
Emailinfo@lympha-press.com
Phone7327929677
Emailinfo@lympha-press.com
Phone7327929677
Emailinfo@lympha-press.com
Phone7327929677
Emailinfo@lympha-press.com
Phone7327929677
Emailinfo@lympha-press.com
Phone7327929677
Emailinfo@lympha-press.com
Phone7327929677
Emailinfo@lympha-press.com
Phone7327929677
Emailinfo@lympha-press.com
Phone7327929677
Emailinfo@lympha-press.com
Phone7327929677
Emailinfo@lympha-press.com
Phone7327929677
Emailinfo@lympha-press.com
Phone7327929677
Emailinfo@lympha-press.com
Phone7327929677
Emailinfo@lympha-press.com
Phone7327929677
Emailinfo@lympha-press.com
Phone7327929677
Emailinfo@lympha-press.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290105870155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOWSleeve, Limb, Compressible

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-06-15
Device Publish Date2019-12-24

Devices Manufactured by MEGO afek Agricultural Cooperative Society Ltd

07290105870155 - 201Max Calibrated device2023-06-15Lympha 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.
07290105870155 - 201Max Calibrated device2023-06-15 Lympha Press® 201Max™ is a calibrated gradient pneumatic compression therapy system for treatment of lymphedema, venous insuf
07290105875402 - Calf&Foot L NRC-DVT2023-02-20 The Calf & Foot L NRC-DVT single-patient use compression garment fastened around the area to be treated. The garment contains ov

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