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Lympha Press Optimal 1201AD

FDA UDI

Class II (US FDA UDI)

by MEGO afek Agricultural Cooperative Society Ltd

Identity

Trade Name
Lympha Press Optimal 1201AD FDA UDI
Generic Name
Sequential venous compression system inflator FDA UDI
Device Name
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. FDA UDI
Model / Reference
1201AD FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
L10003C7U FDA UDI
Primary DI / UDI-DI
07290105878946 FDA UDI
510(k) Number
K082149 FDA UDI
FDA Product Code
JOW FDA UDI
GMDN Term
Sequential venous compression system inflator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Sequential venous compression system inflator

Lympha Press Optimal 1201AD by MEGO afek Agricultural Cooperative Society Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sequential venous compression system inflator.

Cleared under the same submission

K082149 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MEGO afek Agricultural Cooperative Society Ltd

Sources (1)

  • FDA UDI 7ab1dcdd-085d-44f6-bee2-451bc25f8cbf 36 fields · synced Jun 8, 2026