Reality DTx

Basic Information

• Brand Name: Reality DTx
• Primary DI: 05065012458039
• Version / Model: ML2
• Catalog Number: CX-ML2-0001
• Company Name: STROLLL LIMITED
• Labeler DUNS: 224725541
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-22
• Public Version: 2
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: 4ea298d6-b7c5-4c88-aa16-ee312b8fc152

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QKC	Interactive Rehabilitation Exercise Device, Prescription Use	Physical Medicine	890.5360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05065012458039	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]