Duns Number:514658082
Device Description: The PCD-51™ system is a sequential pneumatic compression therapy system for treatment and 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.
Catalog Number
L10015G1
Brand Name
PCD-51 731A (US) - White
Version/Model Number
731A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K121962
Product Code
JOW
Product Code Name
Sleeve, Limb, Compressible
Public Device Record Key
22bc4361-1aae-42c0-a882-4022d9e3e24b
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 |