201Max Calibrated device

FDA UDI

Class II (US FDA UDI)

by MEGO afek Agricultural Cooperative Society Ltd

Identity

Trade Name: 201Max Calibrated device FDA UDI
Generic Name: Sequential venous compression system inflator FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 201Max FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: L1000063 FDA UDI
Primary DI / UDI-DI: 07290105870155 FDA UDI
510(k) Number: K100677 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: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

Yes

FDA UDI

201Max Calibrated device by MEGO afek Agricultural Cooperative Society Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: MEGO afek Agricultural Cooperative Society Ltd

Sources (1)

FDA UDI 0b03a81e-2bbe-4304-9103-2eb8c0fd80dd 37 fields · synced May 29, 2026