AccessGUDID - DEVICE: Reality DTx (05065012458039)

GUDID

Device Identifier (DI) Information

Brand Name: Reality DTx
Version or Model: ML2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CX-ML2-0001
Company Name: STROLLL LIMITED

Primary DI Number: 05065012458039
Issuing Agency: GS1
Commercial Distribution End Date: September 29, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 224725541 *Terms of Use

Device Description: A software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological conditions such as Parkinson’s disease. The software provides visual and auditory stimuli and gamified rehabilitation exercises through a wearable augmented reality headset to engage and motivate adult patients to perform physical exercises under the direction of the physician in charge.

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?
63475	Neuromuscular rehabilitation software	A software program intended to be used by a patient whose neuromuscular abilities have been impaired by a disease/condition (e.g., Parkinson’s, stroke, traumatic brain injury) to help train and regain neuromuscular control (e.g., balance, strength, speech) through guided activities (e.g., visuomotor stimulating onscreen patterns, tailored exercise regimes, interactive games). It is intended to be used on a non-medical computerized device (e.g., tablet, smartphone) for use in the home; it is not intended to interface with external biomechanical function analysis equipment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QKC	Interactive Rehabilitation Exercise Device, Prescription Use

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: 4ea298d6-b7c5-4c88-aa16-ee312b8fc152
Public Version Date: July 09, 2024
Public Version Number: 3
DI Record Publish Date: August 22, 2023