FDA.reportPublic FDA data

Reality DTx

Primary DI
05065012458121
Brand
Reality DTx
Company
STROLLL LIMITED
Model
HL2 v6
Catalog number
CX-HL2-0001
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.
Published
2024-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QKCInteractive Rehabilitation Exercise Device, Prescription Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKCInteractive Rehabilitation Exercise Device, Prescription UsePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05065012458046PreviousGS10
05065012458121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05065012458046050650124580465065012458046
05065012458121050650124581215065012458121

GMDN Terms#

Term, Definition table
TermDefinition
Neuromuscular rehabilitation softwareA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+44 2045584295hello@strolll.co

Regulatory Flags#

DUNS number
224725541
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05065012458138Strolll RehabML2 v1.0Strolll-REHAB-0001-ML22025-12-16
05065012458114Reality DTxML2 v6CX-ML2-00012024-07-08
05065012458039Reality DTxML2CX-ML2-00012023-08-22
05065012458046Reality DTxHL2CX-HL2-00012023-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G693YSV10YourSteps Yoursteps Health, Inc.QKC2026-04-30
088830000113113DGaitCARECAM PTE. LTD.QKC2026-04-22
03760272650699MindMotion Toap Run NeuroXtherapeutics SAQKC2026-04-13
03760272650880MindMotion GO Procedure PackNeuroXtherapeutics SAQKC2026-03-23
03760272650774MindMotion GO Procedure PackNeuroXtherapeutics SAQKC2026-03-16
05694230564040NeckCare HomeNeckCare Holding ehfQKC2026-03-09
07290020097040Kemtai CareKEMTAI LTDQKC2026-02-05
07290020097002Kemtai CareKEMTAI LTDQKC2025-12-23
07290020097019Kemtai CareKEMTAI LTDQKC2025-12-23
07290020097026Kemtai CareKEMTAI LTDQKC2025-12-23
07290020097033Kemtai CareKEMTAI LTDQKC2025-12-23
05065012458138Strolll RehabSTROLLL LIMITEDQKC2025-12-16
00860011881711Proactive StridesVIRTUSENSE TECHNOLOGIES, INC.QKC2025-12-01
00860011881728Proactive YouVIRTUSENSE TECHNOLOGIES, INC.QKC2025-12-01
05694230564026NeckCare ExercisesNeckCare Holding ehfQKC2025-05-30
05391548420005VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-23
05391548420012VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-23
05391548420029VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-20
05391548420036VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-20
05065012458114Reality DTxSTROLLL LIMITEDQKC2024-07-08
G629RESTORESKILLSTHERA0Restore Skills TherapyTIMOCCO USA, INC.QKC2024-06-27
00860011881704VSTBalanceVIRTUSENSE TECHNOLOGIES, INC.QKC2024-06-10
08809970060005EverEx RehabEverExQKC2024-04-03
00196852042524Motion TrainerTrainer Rx, Inc. D/B/A RecoveryoneQKC2023-08-29
05065012458039Reality DTxSTROLLL LIMITEDQKC2023-08-22
05065012458046Reality DTxSTROLLL LIMITEDQKC2023-08-22
05065010464001GaitSmart®DYNAMIC METRICS LIMITEDQKC2023-05-17
G186EXERHEALTH20Exer HealthExer Labs, Inc.QKC2023-03-21
00860008232304EnGauge Physical Rehabilitation SystemVerity Technologies, Inc.QKC2022-08-10
G186EXERPHYSIO20Exer PhysioExer Labs, Inc.QKC2022-01-04