Identity
- Trade Name
- Gloreha Aria FDA UDI
- Generic Name
- Virtual-display rehabilitation system, passive-support, upper-limb FDA UDI
- Device Name
- The Gloreha Aria (GAR) is a sensor-based therapeutic device designed for upper limb rehabilitation and neurocognitive training. The optical sensor detects hand movements and offers interactive programs and games to enhance motor skills, coordination, and visuospatial abilities. Additionally, GAR focuses on improving cognitive functions such as attention, memory, and problem-solving. By integrating motor and cognitive tasks, GAR helps train divided attention, which is essential for performing Activities of Daily Living (ADLs). FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The Gloreha Aria (GAR) is a sensor-based therapeutic device designed for upper limb rehabilitation and neurocognitive training. The optical sensor detects hand movements and offers interactive programs and games to enhance motor skills, coordination, and visuospatial abilities. Additionally, GAR focuses on improving cognitive functions such as attention, memory, and problem-solving. By integrating motor and cognitive tasks, GAR helps train divided attention, which is essential for performing Activities of Daily Living (ADLs). FDA UDI
Identifiers
- Catalog Number
- GAR FDA UDI
- Primary DI / UDI-DI
- 08055713760033 FDA UDI
- FDA Product Code
- ION FDA UDI
- GMDN Term
- Virtual-display rehabilitation system, passive-support, upper-limb FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Virtual-display rehabilitation system, passive-support, upper-limb
Gloreha Aria by Idrogenet Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Idrogenet Srl
Sources (1)
- FDA UDI 1feb2a9c-8f2d-41f6-b992-6ce714a31a70 35 fields · synced May 31, 2026