Duns Number:808204957
Device Description: RF Receiver card to be used in the TeleRehab Receiver Box to receive RF data transmission RF Receiver card to be used in the TeleRehab Receiver Box to receive RF data transmission from transmitters.
Catalog Number
100007
Brand Name
TeleRehab Receiver Card
Version/Model Number
TeleRehab Receiver Card
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K050778
Product Code
DRG
Product Code Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Public Device Record Key
45eb9b0e-7727-4500-80fe-1c07ec93277d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 19, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |