Lympha Jacket,Short Arm NRC-JKT - The Lympha Jacket Short Arm NRC-JKT compression - MEGO afek Agricultural Cooperative Society Ltd

Duns Number:514658082

Device Description: The Lympha Jacket Short Arm NRC-JKT compression garment fastened around the area to be tre The Lympha Jacket Short Arm NRC-JKT 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.

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More Product Details

Catalog Number

L4MJ2125

Brand Name

Lympha Jacket,Short Arm NRC-JKT

Version/Model Number

LP Jacket Short Arm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K013331

Product Code Details

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Device Record Status

Public Device Record Key

a61d08ff-30ed-442e-bff8-0c6c3fe0db84

Public Version Date

January 01, 2020

Public Version Number

1

DI Record Publish Date

December 24, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEGO AFEK AGRICULTURAL COOPERATIVE SOCIETY LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 100