Device
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...
Manufacturer
Yoursteps Health, Inc.
Yoursteps Health, Inc.
Model: Ver. 1.0
Catalog: YSV1
DI: G693YSV10
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3625d24f-e80c-4b38-b498-43ee6438cdc6
Distribution Status:
In Commercial Distribution
DUNS Number:
108282142
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
G693YSV10
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 63475
Name: Physical/neuromuscular rehabilitation software
Definition:
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.
FDA Product Codes
QKC
Interactive Rehabilitation Exercise Device, Prescription Use