Lympha Press Optimal Plus(US) BT - The Lympha Press® Optimal Plus system is a - MEGO afek Agricultural Cooperative Society Ltd

Duns Number:514658082

Device Description: The Lympha Press® Optimal Plus system is a multi-zone calibrated gradient pneumatic compre 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.

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More Product Details

Catalog Number

L10008C2-US

Brand Name

Lympha Press Optimal Plus(US) BT

Version/Model Number

912

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K182003

Product Code Details

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Device Record Status

Public Device Record Key

bd8c93c8-0585-4e03-8375-e734fd59ede2

Public Version Date

January 01, 2020

Public Version Number

1

DI Record Publish Date

December 24, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEGO AFEK AGRICULTURAL COOPERATIVE SOCIETY LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 100