Identity
- Trade Name
- Gloreha Professional 2 FDA UDI
- Generic Name
- Virtual-display rehabilitation system, powered-support, upper-limb FDA UDI
- Device Name
- The Gloreha Professional 2 (GP2) is a neuromotor rehabilitation device designed to support recovery for patients with neuromuscular impairments. This electrically powered device mobilizes the metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints, aiding finger movement. Through an interactive virtual software program, GP2 combines motor therapy with visual and auditory stimuli. This targeted approach helps rehabilitate upper limb functionality by reinforcing motor patterns essential for daily tasks. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The Gloreha Professional 2 (GP2) is a neuromotor rehabilitation device designed to support recovery for patients with neuromuscular impairments. This electrically powered device mobilizes the metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints, aiding finger movement. Through an interactive virtual software program, GP2 combines motor therapy with visual and auditory stimuli. This targeted approach helps rehabilitate upper limb functionality by reinforcing motor patterns essential for daily tasks. FDA UDI
Identifiers
- Catalog Number
- GP2 FDA UDI
- Primary DI / UDI-DI
- 08055713760019 FDA UDI
- FDA Product Code
- BXB FDA UDI
- GMDN Term
- Virtual-display rehabilitation system, powered-support, upper-limb FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5380 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, powered-support, upper-limb
Gloreha Professional 2 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 2bddca02-344d-4948-96b3-c721486d59d0 35 fields · synced May 30, 2026