Duns Number:084042331
Device Description: The PlasmaWave is a game changing portable pneumatic SCD device used in the home or clinic The PlasmaWave is a game changing portable pneumatic SCD device used in the home or clinical setting. It carries a market leading 25+ hour battery and two calf sleeves.Portable and lightweightLong lasting re-chargeable battery - up to 26 hours of use on one charge2 Modes: Slow inflation and Step-Up Technology which allows the unit to increase pressure in slower increments1 LCD screen to monitor usage, pressure, and battery lifeHospital or surgery center conversion kit - over 8ft of reusable tubing, disposable SCD sleeves, and a stationary bed rack
Catalog Number
PWAVE01
Brand Name
ManaMed
Version/Model Number
PlasmaWave
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
-
Product Code
IRP
Product Code Name
Massager, Powered Inflatable Tube
Public Device Record Key
14bd3ea2-d265-48d4-83bd-a4880f7e429c
Public Version Date
July 11, 2022
Public Version Number
1
DI Record Publish Date
July 01, 2022
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 | 128 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |