Optimal 1201AD Optimized for Pod

FDA UDI

Class II (US FDA UDI)

by MEGO afek Agricultural Cooperative Society Ltd

Identity

Trade Name: Optimal 1201AD Optimized for Pod FDA UDI
Generic Name: Sequential venous compression system inflator FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 1201AD FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: L10003C7P FDA UDI
Primary DI / UDI-DI: 07290105878939 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Sequential venous compression system inflator

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

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Cleared under the same submission

K082149 also covers:

Lympha Press Optimal 1201AD — MEGO afek Agricultural Cooperative Society Ltd

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 70ad6c47-acd1-4127-8c16-8e97a74785ed 36 fields · synced Jun 8, 2026