REEV SENSE - Gait Analysis System for Healthcare Professionals
Our mission is to help millions of people with neurological walking disorders to overcome their daily handicap
/!\ MEDICAL DEVICE - FOR PROFESSIONAL USE ONLY
REEV SENSE is a medical device intended for use by qualified healthcare professionals in clinical settings to perform quantitative gait analysis.
INTENDED USE:
REEV SENSE provides biomechanical gait modeling including spatio-temporal parameters and knee and ankle kinematics to assist healthcare professionals in their clinical assessment of patient gait patterns.
CLINICAL VALIDATION:
REEV SENSE is validated for gait analysis in post-stroke patient populations.
IMPORTANT LIMITATIONS:
- REEV SENSE is an assessment tool only - it does NOT provide medical diagnosis
- Results are intended to support, not replace, professional clinical judgment
- Clinical interpretation by qualified healthcare professionals is required
- Not intended to influence treatment decisions independently
REEV SENSE is a certified MDR Class I device.
REEV SENSE is a FDA listed medical device.
Ratings & Reviews
5.0
out of 5
2 Ratings
We’re continuing to enhance the SENSE app! Check out the latest features and improvements designed to give you an even better experience.
### New
- Access all therapist results from Home screen
- Results-Reports: multiple selection & batch actions (delete, report generation, ZIP download)
-
### Improved
- Lists: swipe to delete, pagination, pull-to-refresh, period filters (All-This week-Today)
- Patient: auto navigate to next screen after creation
- Global design, code structure & performance improvements
Version 2.1.2
The developer, REEV SAS, indicated that the app’s privacy practices may include handling of data as described below. For more information, see the developer’s privacy policy .
Data Linked to You
The following data may be collected and linked to your identity:
Contact Info
Data Not Linked to You
The following data may be collected but it is not linked to your identity:
Health & Fitness
Location
Diagnostics
Privacy practices may vary, for example, based on the features you use or your age. Learn More
Accessibility
The developer has not yet indicated which accessibility features this app supports. Learn More
REEV SAS indicated this app is a regulated medical device and complies with United States law.
The information below has not been verified by Apple.
FDA Owner/Operator Number
10089096
Address
10 AVENUE EDOUARD BELIN 31400 TOULOUSE France
Phone Number
+33 5 36 99 00 80
Email
admin@reev.care
Use Statement
REEV SENSE is indicated for use in clinical settings (such as hospitals and rehabilitation centers) on adult, ambulatory post-stroke patients with gait impairments. The device provides objective analysis and monitoring of knee and ankle kinematics, as well as spatiotemporal gait parameters. REEV SENSE is to be used solely under the supervision of a healthcare professional
Safety Information
WARNING: • No modification of this equipment is allowed. • Store and/or transport only between -25°C/-13°F and +70°C/+158°F. • Use only between +5°C/+41°F and +40°C/+104°F. • Store and/or transport only below 90% humidity. • Use only between 15% and 90% humidity. • Do not use near life sustaining devices. • Do not use the system if a magnet is missing or broken. • The MEU and the detachable parts are to be worn over clothing and not to be in contact with the patient’s skin during use. • Ensure that each sensor, strap and pod is properly placed: any misplacement or sensor exchange will lead to analysis errors. • Follow specified cleaning instructions. • Use only specified cleaning products. • Do not use the device beyond its expected lifetime. • Do not use in or near electromagnetically noisy environments (MRI room, HF surgical equipment). • Do not discard the device, please contact your distributor or manufacturer to ensure proper recycling. • In the case of severe gait abnormalities, results of gait analysis may be unreliable. • Use only with power supply output limited to 15W/900J to supply the charging station. • Use at least iOS 15.5 or Android 7.0 to install the application • Use the mobile application on a device with location services and Bluetooth enabled. • Use at least Bluetooth 4.0.
RESIDUAL RISKS: If a MEU is not aligned with the charging station the battery can overheat. => Make sure to correctly align the MEU with the charging station. Battery can overheat due to internal short circuit. If the user uses an improper power supply (output greater than 15W/900J), the battery can overheat. => Do not use if the device is hot or blazing. Electrostatic discharges can occur and cause the battery to overheat. Electromagnetic disturbances created by the device can cause other devices to malfunction. => Do not use near life sustaining devices. Using device beyond its expected lifetime can lead to a battery leakage and can cause overheating. => Do not use the device beyond its expected service life. Missing or illegible labeling can lead to unsafe use of the device. => Do not use the device if labels and IFU are missing and/or unreadable. If the device is not stored and/or transported within the specified temperature and/or humidity conditions the battery cannot withstand the conditions and may explode or malfunction. => Do not use the device or use it carefully if you are not sure of the conditions under which it has been stored and transported. Repeated contact with nickel may cause irritation and/or allergy => Avoid prolonged contact between the skin and the pod magnets. Some people may develop allergies due to repeated contact with nickel => If you have known allergies to nickel avoid all contact with the magnets. Any serious incident involving the device must be notified to the manufacturer and to the competent authority of the Member State in which the user and/or patient is established, or any relevant regulatory authority.
