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PCD-51 731A (US) - White

MEGO afek Agricultural Cooperative Society Ltd · Model 731A · UDI-DI 07290105879332

JOW Prescription

510(k) clearances

1,711

Adverse events (19 deaths)

Recalls

139

Facilities

Description

The PCD-51™ system is a sequential pneumatic compression therapy system for treatment and management of lymphedema, venous insufficiency, venous stasis ulcers and dysfunction of the "muscle pump". The PCD-51™ system consists of: • The console (sometimes called "compressor" or "pump"). It supplies air at regulated pressure to a compression garment that is worn around 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 is fastened around the area to be treated. Each garment contains 4 overlapping air chambers. These 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 of the PCD-51™ system 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 lymphatic vessels and return to the blood circulation. The directional compressive massage also helps reduce venous edema and stimulates venous return.

Recalls

Date	Firm	Reason
2025-05-13	Cardinal Health 200, LLC	Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
2025-05-13	Cardinal Health 200, LLC	Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
2025-05-13	Cardinal Health 200, LLC	Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
2023-04-14	Stryker Sustainability Solutions	Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
2021-07-09	Ortho8, Inc.	EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
2021-07-09	Ortho8, Inc.	CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
2019-04-08	Compass Health Brands (Corporate Office)	Product design change did not receive proper premarket clearance and lacks a 510 (k)
2019-04-08	Compass Health Brands (Corporate Office)	Product design change did not receive proper premarket clearance and lacks a 510 (k)
2019-04-08	Compass Health Brands (Corporate Office)	Product design change did not receive proper premarket clearance and lacks a 510 (k)
2019-04-08	Compass Health Brands (Corporate Office)	Product design change did not receive proper premarket clearance and lacks a 510 (k)

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.