Duns Number:534078621
Device Description: The ReoGoTM therapy platform is a computerized robotics-based system for retraining patien The ReoGoTM therapy platform is a computerized robotics-based system for retraining patients with motor limitations, recovering from CVA or other neuromuscular conditions. The Motorika ReoGo™ System is rehabilitative exercise device intended for medical purposes, such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints specifically designed to prevent the adhesion and contracture of joints, to improve the patients’ range of motion and functional capabilities of the upper extremity.
Catalog Number
REOGO005SYS
Brand Name
REOGO
Version/Model Number
08
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
IKK
Product Code Name
System, Isokinetic Testing And Evaluation
Public Device Record Key
8877a4e7-6278-41a3-a9ba-2456c7e87247
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
May 31, 2019
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |