FDA UDI
In Commercial Distribution
🇺🇸 United States
AMADEO
DI: 09120077180014
·
Model: 7
·
tyromotion GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AMADEO
- Primary DI
- 09120077180014
- Version / Model
- 7
- Company Name
- tyromotion GmbH
- Labeler DUNS
- 301726803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-18
- Public Version
- 1
- Public Version Date
- 2022-09-26
- Public Version Status
- New
- Public Device Record Key
- fc4d9fa8-f700-4c53-ba89-e26cfba64ff9
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BXB | Exerciser, Powered | Physical Medicine | 890.5380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47517 | Virtual-display rehabilitation system, powered-support, upper-limb | An assembly of devices intended to be used in a clinical setting to provide gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the upper limbs (e.g., impaired arm function) through patient interaction with a videogame-like display prompting repeated motion of the limb under treatment (e.g., arm, hand, wrist, shoulder) for functional improvement (e.g., reaching, grasping); it may also provide performance feedback and manual/automatic setting adjustments. It consists of a limb support capable of actively assisting the patient’s movements (e.g., powered robotic arm), and a computer/monitor with software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09120077180014 | GS1 |