Lympha Press Optimal Plus(US) BT L10008C2-US

GUDID 07290105879110

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.

MEGO afek Agricultural Cooperative Society Ltd

Sequential venous compression system inflator
Primary Device ID07290105879110
NIH Device Record Keybd8c93c8-0585-4e03-8375-e734fd59ede2
Commercial Distribution StatusIn Commercial Distribution
Brand NameLympha Press Optimal Plus(US) BT
Version Model Number912
Catalog NumberL10008C2-US
Company DUNS514658082
Company NameMEGO afek Agricultural Cooperative Society Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
Phone7327929677
Emailinfo@lympha-press.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290105879110 [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 Date2024-09-19
Device Publish Date2019-12-24

Devices Manufactured by MEGO afek Agricultural Cooperative Society Ltd

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07290105879110 - Lympha Press Optimal Plus(US) BT2024-09-19The 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.
07290105879110 - Lympha Press Optimal Plus(US) BT2024-09-19 The Lympha Press® Optimal Plus system is a multi-zone calibrated gradient pneumatic compression therapy system for treatment of

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