Duns Number:084042331
Device Description: The PlasmaFlight is a portable and rechargeable device. It is intended to be an over-the-c The PlasmaFlight is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.
Catalog Number
-
Brand Name
PlasmaFlight
Version/Model Number
FLIGHT001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K200351
Product Code
IRP
Product Code Name
Massager, Powered Inflatable Tube
Public Device Record Key
6ce6e0fe-bb8a-4458-b254-2f97f4e3778e
Public Version Date
November 10, 2020
Public Version Number
1
DI Record Publish Date
November 02, 2020
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 |