Duns Number:301726803
Device Description: The AMADEO system is intended for robot-supported finger-hand therapy of patients with neu The AMADEO system is intended for robot-supported finger-hand therapy of patients with neurological damage to the central nervous system, caused by typical indications such as stroke or traumatic brain injury.
Catalog Number
-
Brand Name
AMADEO
Version/Model Number
7
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
-
Product Code
BXB
Product Code Name
Exerciser, Powered
Public Device Record Key
fc4d9fa8-f700-4c53-ba89-e26cfba64ff9
Public Version Date
September 26, 2022
Public Version Number
1
DI Record Publish Date
September 18, 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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |