Duns Number:757258843
Device Description: Application- impedance analysis software utilizing impedance ratios that are displayed as Application- impedance analysis software utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular fluidvolume differences between the limbs and is presented to the clinician on an L-Dex scale.
Catalog Number
SOZOthrive
Brand Name
SOZOThrive
Version/Model Number
1.1.0
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 21, 2019
Issuing Agency
In HIBCC
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
K172122
Product Code
OBH
Product Code Name
Monitor, Extracellular Fluid, Lymphedema, Extremity
Public Device Record Key
e667c5fe-5ae7-46e2-8085-10f074742200
Public Version Date
June 15, 2022
Public Version Number
4
DI Record Publish Date
October 02, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |