PCD-52™ 737A (US) White L10015H1
GUDID 07290105879431
The PCD-52™ 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", and edemas caused by trauma and immobility. The PCD-52™ 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 PCD-52™ 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-52™ 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 lymphatics 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 | 07290105879431 |
| NIH Device Record Key | 9c7fd723-2042-4c01-83ff-da019d3c7058 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PCD-52™ 737A (US) White |
| Version Model Number | 737A |
| Catalog Number | L10015H1 |
| 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 |
| info@lympha-press.com | |
| Phone | 7327929677 |
| info@lympha-press.com | |
| Phone | 7327929677 |
| info@lympha-press.com | |
| Phone | 7327929677 |
| info@lympha-press.com | |
| Phone | 7327929677 |
| info@lympha-press.com | |
| Phone | 7327929677 |
| info@lympha-press.com | |
| Phone | 7327929677 |
| info@lympha-press.com | |
| Phone | 7327929677 |
| info@lympha-press.com | |
| Phone | 7327929677 |
| info@lympha-press.com | |
| Phone | 7327929677 |
| info@lympha-press.com | |
| Phone | 7327929677 |
| info@lympha-press.com | |
| Phone | 7327929677 |
| info@lympha-press.com | |
| Phone | 7327929677 |
| info@lympha-press.com | |
| Phone | 7327929677 |
| info@lympha-press.com | |
| Phone | 7327929677 |
| info@lympha-press.com | |
| Phone | 7327929677 |
| info@lympha-press.com | |
| Phone | 7327929677 |
| info@lympha-press.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290105879431 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140642
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 |
Devices Manufactured by MEGO afek Agricultural Cooperative Society Ltd
| 07290105871213 - Ballancer 505 1201-AC USA | 2024-09-19 Ballancer® 505 is a massage system intended for use by people in good health. As noted above, Ballancer® 505 simulates the kne |
| 07290105871480 - Nano Press 760A (US) | 2024-09-19 The NanoPress™ system is a sequential pneumatic compression therapy system for treatment and management of lymphedema, venous |
| 07290105871497 - RP Lite 760R | 2024-09-19 RP Lite® is a massage system intended for use by people in good health. As noted above, RP Lite® simulates the kneading and st |
| 07290105878670 - Ballancer 505 V2 1201-AC | 2024-09-19 Ballancer® 505 V2 is a massage system intended for use by people in good health. As noted above, Ballancer® 505 V2 simulates t |
| 07290105878939 - Optimal 1201AD Optimized for Pod | 2024-09-19 Lympha Press Optimal® Optimized for LymphaPod® is a multi-zone calibrated gradient pneumatic compression therapy system for tr |
| 07290105878946 - Lympha Press Optimal 1201AD | 2024-09-19 Lympha Press Optimal® system is a multi-zone calibrated gradient pneumatic compression therapy system for treatment of lymphede |
| 07290105879042 - Phlebo Press DVT 760D (US) | 2024-09-19 The Phlebo Press® DVT system is a pneumatic compression therapy system used to help prevent deep vein thrombosis in patients wh |
| 07290105879110 - Lympha Press Optimal Plus(US) BT | 2024-09-19 The Lympha Press® Optimal Plus system is a multi-zone calibrated gradient pneumatic compression therapy system for treatment of |
Trademark Results [PCD-52]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PCD-52 86551267 5069398 Live/Registered |
Mego Afek AC Ltd. 2015-03-03 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.