AccessGUDID - DEVICE: Heaxel (08054329990001)

GUDID

Device Identifier (DI) Information

Brand Name: Heaxel
Version or Model: ICONE
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HEALTH PIXEL SRL

Primary DI Number: 08054329990001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 439706071 *Terms of Use

Device Description: Robotic system for neurorehabilitation and rehabilitation of the upper limbs and shoulders of patients with neuromotor disabilities.

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):	Yes
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
IKK	System, Isokinetic Testing And Evaluation
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: e05a05e0-3941-4066-9455-6f418b55cdd0
Public Version Date: August 05, 2022
Public Version Number: 3
DI Record Publish Date: August 07, 2020