Identity
- Trade Name
- Gloreha Active Package FDA UDI
- Generic Name
- Virtual-display rehabilitation system, powered-support, upper-limb FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- GAP FDA UDI
- Primary DI / UDI-DI
- 08055713760026 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 Active Package 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 d16fa7bd-c029-4838-a3ba-96db6210594f 35 fields · synced May 30, 2026