Reality DTx

Basic Information

• Brand Name: Reality DTx
• Primary DI: 05065012458114
• Version / Model: ML2 v6
• 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: 2024-07-08
• Public Version: 2
• Public Version Date: 2026-03-17
• Public Version Status: Update
• Public Device Record Key: 7f6fac46-6d1d-4223-8ba7-7c1d1a4cdfbc

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	Physical/neuromuscular rehabilitation software	A software program intended to help a patient regain functional physical and/or neuromuscular control through guided activities (e.g., physiotherapy exercises, visuomotor stimulating onscreen patterns, interactive games, speech exercises), in cases of musculoskeletal, neurological, and/or oral-motor conditions/events (e.g., trauma, Parkinson’s, stroke, traumatic brain injury). It is intended to be used in the home on a non-medical device (e.g., tablet, smartphone, computer); it is not intended to interface with external biomechanical function analysis equipment. Some types involve clinical supervision or consultation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05065012458114	GS1
Previous	05065012458039	GS1

Customer Contacts

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