YourSteps

Primary DI
G693YSV10
Brand
YourSteps
Company
Yoursteps Health, Inc.
Model
Ver. 1.0
Catalog number
YSV1
Device description
YourSteps is a smart phone-based software platform intended for use on rehabilitation patients to provide an interactive rehabilitation environment by providing exercises for users to perform. YourSteps uses the smart phone’s accelerometer as a sensor along with its internal camera and screen to track user movement and provide visual feedback. The device is intended to be set-up and used in the presence of a trained health care provider in a clinical setting, although patient set-up could be conducted via a videoconferencing session and subsequent treatment sessions may be conducted remotely in a patient’s home environment. This initial patient population is pediatric cancer patients, pediatric rehabilitation patients and young adult rehabilitation patients.
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
G693YSV10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Physical/neuromuscular rehabilitation softwareA 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.

Regulatory Flags#

DUNS number
108282142
Device count
1
Premarket exempt
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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07290020097019Kemtai CareKEMTAI LTDQKC2025-12-23
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07290020097033Kemtai CareKEMTAI LTDQKC2025-12-23
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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
05065012458121Reality 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