FDA.reportPublic FDA data

Lympha Press 4 4-85 NRC-LEG

Primary DI
07290105875969
Brand
Lympha Press 4 4-85 NRC-LEG
Company
MEGO afek Agricultural Cooperative Society Ltd
Model
LP 4 4-85
Catalog number
L41F2485H
Device description
The Lympha Press 4 4-85 NRC-LEG compression garment fastened around the area to be treated. The 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 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.
Published
2019-12-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060220000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060220000PBS MODEL 701A COMPRESSION THERAPY DEVICEMego Afek2006-02-09JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290105875969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290105875969072901058759697290105875969

GMDN Terms#

Term, Definition table
TermDefinition
Multi-chamber venous compression system garment, reusableAn inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
7327929677info@lympha-press.com
8885967421info@patriotmedical.com

Regulatory Flags#

DUNS number
514658082
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290105871213Ballancer 505 1201-AC USA1201ACL10505CBA2019-12-24
07290105871480Nano Press 760A (US)760AL10007A2-US2019-12-24
07290105871497RP Lite 760R760RL10007AR2019-12-24
07290105878670Ballancer 505 V2 1201-AC1201ACL10004C6-US2019-12-24
07290105878939Optimal 1201AD Optimized for Pod1201ADL10003C7P2019-12-24
07290105878946Lympha Press Optimal 1201AD1201ADL10003C7U2019-12-24
07290105879042Phlebo Press DVT 760D (US)760DL10007D42019-12-24
07290105879110Lympha Press Optimal Plus(US) BT912L10008C2-US2019-12-24
07290105879165Ballancer Gold (US)12122019-12-24
07290105879325RPX 737R Device 2020737RL10005H2R-US2019-12-24
07290105879332PCD-51 731A (US) - White731AL10015G12019-12-24
07290105879431PCD-52™ 737A (US) White737AL10015H12019-12-24
07290105870155201Max Calibrated device201MaxL10000632019-12-24
07290105875402Calf&Foot L NRC-DVTDVT C&F L SPUL4ZD23302023-02-12
07290105872685#4 Adult Boot XL (4 cells)4 Boot XLL41204402019-12-24
07290105872692Adult Boot # 1A RC-FLSBoot 1AL41211102019-12-24
07290105872708Adult boot No. 2A RC-FLSBoot 2AL41212102019-12-24
07290105872791FL sleeve 2-75 RC-FLSFL 2-75L41320752019-12-24
07290105872807FL sleeve 2-85 RC-FLSFL 2-85L41320852019-12-24
07290105872852FL sleeve 3-85 RC-FLSFL 3-85L41330852019-12-24

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