Duns Number:688817949
Device Description: Sequential compression pump with 2 leg sleeve (XL), 1 double hose and 1 single hose.
Catalog Number
-
Brand Name
Compressible Limb Therapy System
Version/Model Number
LX7(V7)
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
K102320,K102320
Product Code
IRP
Product Code Name
Massager, Powered Inflatable Tube
Public Device Record Key
67356ae6-f809-4052-8d77-059c0192ec4b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 04, 2016
Package DI Number
28809315677824
Quantity per Package
2
Contains DI Package
18809315677827
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 175 |