Duns Number:439706071
Device Description: Robotic system for neurorehabilitation and rehabilitation of the upper limbs and shoulders Robotic system for neurorehabilitation and rehabilitation of the upper limbs and shoulders of patients with neuromotor disabilities.
Catalog Number
-
Brand Name
Heaxel
Version/Model Number
ICONE
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
BXB
Product Code Name
Exerciser, Powered
Public Device Record Key
e05a05e0-3941-4066-9455-6f418b55cdd0
Public Version Date
August 05, 2022
Public Version Number
3
DI Record Publish Date
August 07, 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 | 1 |