Optimal 1201AD Optimized for Pod L10003C7P

GUDID 07290105878939

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.

MEGO afek Agricultural Cooperative Society Ltd

Sequential venous compression system inflator
Primary Device ID07290105878939
NIH Device Record Key70ad6c47-acd1-4127-8c16-8e97a74785ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptimal 1201AD Optimized for Pod
Version Model Number1201AD
Catalog NumberL10003C7P
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
GS107290105878939 [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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07290105878939 - Optimal 1201AD Optimized for Pod2024-09-19Lympha 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.
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