Reality DTx CX-ML2-0001

GUDID 05065012458114

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.

STROLLL LIMITED

Neuromuscular rehabilitation software

• Primary Device ID: 05065012458114
• NIH Device Record Key: 7f6fac46-6d1d-4223-8ba7-7c1d1a4cdfbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reality DTx
• Version Model Number: ML2 v6
• Catalog Number: CX-ML2-0001
• Company DUNS: 224725541
• Company Name: STROLLL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +44 2045584295
• Email: hello@strolll.co
• Phone: +44 2045584295
• Email: hello@strolll.co
• Phone: +44 2045584295
• Email: hello@strolll.co
• Phone: +44 2045584295
• Email: hello@strolll.co
• Phone: +44 2045584295
• Email: hello@strolll.co
• Phone: +44 2045584295
• Email: hello@strolll.co
• Phone: +44 2045584295
• Email: hello@strolll.co
• Phone: +44 2045584295
• Email: hello@strolll.co
• Phone: +44 2045584295
• Email: hello@strolll.co
• Phone: +44 2045584295
• Email: hello@strolll.co
• Phone: +44 2045584295
• Email: hello@strolll.co
• Phone: +44 2045584295
• Email: hello@strolll.co
• Phone: +44 2045584295
• Email: hello@strolll.co
• Phone: +44 2045584295
• Email: hello@strolll.co
• Phone: +44 2045584295
• Email: hello@strolll.co
• Phone: +44 2045584295
• Email: hello@strolll.co
• Phone: +44 2045584295
• Email: hello@strolll.co

Device Identifiers

Device Issuing Agency	Device ID
GS1	05065012458039 [Previous]
GS1	05065012458114 [Primary]

FDA Product Code

• QKC: Interactive Rehabilitation Exercise Device, Prescription Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-16
• Device Publish Date: 2024-07-08

On-Brand Devices [Reality DTx]

• 05065012458046: A software-only medical device intended to improve functional mobility in states of physical imp
• 05065012458039: A software-only medical device intended to improve functional mobility in states of physical imp
• 05065012458121: A software-only medical device intended to improve functional mobility in states of physical imp
• 05065012458114: A software-only medical device intended to improve functional mobility in states of physical imp