Gloreha Active Package

Basic Information

• Brand Name: Gloreha Active Package
• Primary DI: 08055713760026
• Version / Model: 1
• Catalog Number: GAP
• 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: 1
• Public Version Date: 2024-11-12
• Public Version Status: New
• Public Device Record Key: d16fa7bd-c029-4838-a3ba-96db6210594f

Device Description

The Gloreha Active Package (GAP) is a neuromotor rehabilitation device designed to support recovery for patients with neuromuscular impairments. It consists of a set of sensorized gloves connected to a control system that detects and processes movement data. This device facilitates the recognition, enhancement, and training of active finger flexion and extension movements, promoting effective motor recovery. GAP also supports bimanual therapy, active-assisted exercises, and interactive rehabilitation games, providing an engaging and dynamic therapy experience.

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
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	08055713760026	GS1

Customer Contacts

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