PCD-51 731A (US) - White L10015G1

GUDID 07290105879332

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.

MEGO afek Agricultural Cooperative Society Ltd

Sequential venous compression system inflator

• Primary Device ID: 07290105879332
• NIH Device Record Key: 22bc4361-1aae-42c0-a882-4022d9e3e24b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCD-51 731A (US) - White
• Version Model Number: 731A
• Catalog Number: L10015G1
• Company DUNS: 514658082
• Company Name: MEGO afek Agricultural Cooperative Society Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7327929677
• Email: info@lympha-press.com
• Phone: 7327929677
• Email: info@lympha-press.com
• Phone: 7327929677
• Email: info@lympha-press.com
• Phone: 7327929677
• Email: info@lympha-press.com
• Phone: 7327929677
• Email: info@lympha-press.com
• Phone: 7327929677
• Email: info@lympha-press.com
• Phone: 7327929677
• Email: info@lympha-press.com
• Phone: 7327929677
• Email: info@lympha-press.com
• Phone: 7327929677
• Email: info@lympha-press.com
• Phone: 7327929677
• Email: info@lympha-press.com
• Phone: 7327929677
• Email: info@lympha-press.com
• Phone: 7327929677
• Email: info@lympha-press.com
• Phone: 7327929677
• Email: info@lympha-press.com
• Phone: 7327929677
• Email: info@lympha-press.com
• Phone: 7327929677
• Email: info@lympha-press.com
• Phone: 7327929677
• Email: info@lympha-press.com
• Phone: 7327929677
• Email: info@lympha-press.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290105879332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121962

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-09-19
• Device Publish Date: 2019-12-24

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