Duns Number:514658082
Device Description: Lympha Press® 201Max™ is a calibrated gradient pneumatic compression therapy system for tr Lympha Press® 201Max™ is a calibrated gradient pneumatic compression therapy system for treatment of lymphedema, venous insufficiency, venous stasis ulcers and dysfunction of the "muscle pump".The Lympha Press® 201Max™ system consists of:• The console (sometimes called "compressor" or "pump"), supplying air at fixed 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 cells in the compression garment.• The compression garment (sometimes called a "sleeve"), fastened around the area to be treated. Each garment contains up to 24 overlapping air cells. These air cells are filled with air from the console in sequence, applying a compressive massage. Once the entire limb has been compressed, Lympha Press® 201Max™ 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 Lympha Press® 201Max™ 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.
Catalog Number
L1000063
Brand Name
201Max Calibrated device
Version/Model Number
201Max
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K100677
Product Code
JOW
Product Code Name
Sleeve, Limb, Compressible
Public Device Record Key
0b03a81e-2bbe-4304-9103-2eb8c0fd80dd
Public Version Date
January 01, 2020
Public Version Number
1
DI Record Publish Date
December 24, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 100 |