Duns Number:416757473
Device Description: The product is suitable for patients with certain hand movement ability, which can improve The product is suitable for patients with certain hand movement ability, which can improve the precise control ability of the hand through assisting the hand to realize different gestures and movements. In addition, it can be applied in various training modes such as passive training, mirror training, active training, resistance training, power-assisted training and voice control training, to stimulate and intervene patients' central and peripheral nerves, which is helpful to the recovery of hand movement function of patients.
Catalog Number
BXB
Brand Name
Syrebo
Version/Model Number
SY-HR
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
3288eaec-36bd-4599-ba16-1ff514d24ab7
Public Version Date
June 01, 2021
Public Version Number
1
DI Record Publish Date
May 24, 2021
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 | 1 |