AccessGUDID - DEVICE: Gloreha Professional 2 (08055713760019)

GUDID

Device Identifier (DI) Information

Brand Name: Gloreha Professional 2
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GP2
Company Name: IDROGENET SRL

Primary DI Number: 08055713760019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432036157 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXB	Exerciser, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2bddca02-344d-4948-96b3-c721486d59d0
Public Version Date: November 12, 2024
Public Version Number: 1
DI Record Publish Date: November 04, 2024