Duns Number:688817949
Device Description: Compressible Limb Therapy System pump with 2leg sleeves(Extra large), 1waist sleeve, 1arm Compressible Limb Therapy System pump with 2leg sleeves(Extra large), 1waist sleeve, 1arm sleeve and 4single hoses.
Catalog Number
-
Brand Name
Compressible Limb Therapy System
Version/Model Number
MK300L
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
K112441
Product Code
IRP
Product Code Name
Massager, Powered Inflatable Tube
Public Device Record Key
29df54eb-4cd8-4573-b801-29cf8e3b70ea
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 24, 2016
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 |
|---|---|---|
| 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 |