Duns Number:688817949
Device Description: 4Chamber one-touch center-body sleeve (one size) with 2 extension zipper
Catalog Number
-
Brand Name
Compressible Limb Therapy System(LX7(V7))
Version/Model Number
ACg0413
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 11, 2017
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
Product Code
IRP
Product Code Name
Massager, Powered Inflatable Tube
Public Device Record Key
1592ed70-675b-4da1-8dbb-f28097d8a856
Public Version Date
July 17, 2018
Public Version Number
4
DI Record Publish Date
December 11, 2017
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 |