Gloreha Aria

Basic Information

• Brand Name: Gloreha Aria
• Primary DI: 08055713760033
• Version / Model: 1
• Catalog Number: GAR
• Company Name: IDROGENET SRL
• Labeler DUNS: 432036157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-04
• Public Version: 2
• Public Version Date: 2024-12-23
• Public Version Status: Update
• Public Device Record Key: 1feb2a9c-8f2d-41f6-b992-6ce714a31a70

Device 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).

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: Yes
• Has Manufacturing Date: No
• 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
ION	Exerciser, Non-Measuring	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48147	Virtual-display rehabilitation system, passive-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. It consists of a non-powered weight support (e.g., suspension sling, armrest) whereby the patient’s movements are detected by and presented on a dedicated computer/monitor with software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08055713760033	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]