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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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ReWalk RWE Study


 
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General
Study Status Progress Adequate
522 Number / Requirement Number PS140001 / PSS002
Date Current Plan Accepted  
Study Name ReWalk RWE Study
Root Document Number K131798 
General Study Protocol Parameters
Study Population
Detailed Study Protocol Parameters
Study Design Description Long-term, non-interventional, non-randomized, observational study.



Two study arms: (1) Worldwide SalesForce CRM Database,

(2) Questionnaire. Questionnaire includes: Subjects, their Companions, and their Clinician Trainers.

Study Population Description (1) SalesForce CRM Database: All worldwide users of the ReWalk device

(2) Questionaire: All US current and previous device owners (i.e., subjects), their companion(s), and their clinician trainer(s)

Sample Size (1) SalesForce CRM Database: All worldwide users of the ReWalk device

(2) Questionaire: All US current and previous device owners (i.e., subjects), their companion(s), and their clinician trainer(s)

Data Collection • Long-term safety of the ReWalk Device for subjects in institutional and non-institutional environments, as measured by all adverse events reported to ReWalk Robotics

• Long-term safety of the ReWalk Device for subjects in institutional and non-institutional environments, as measured by the incidence of falls and fall- assocaited injuries reported through the questionnaire(s) and database

• Long-term safety of the ReWalk Device for companions in institutional and non-institutional environments, as measured by all adverse events reported to ReWalk Robotics

• Adequacy and success rate of the training program of the ReWalk Device for subjects and companions, as measured by the database, training records, and questionnaires.

• Adequacy of the training program of the ReWalk device for subjects and companions as measured by the subjects’ proficiency in using device as documented in the questionnaires and step tracking data.

• Reliability of the ReWalk Device, as measured by the incidences of all device malfunctions

• Incidnece of unexpected adverse events

Follow-up Visits and Length of Follow-up The study is an “all comers” registry study, using worldwide data from the ReWalk Robotics SalesForce CRM Database. The questionnaire arm cohort will be recruited from all US based subjects who had or continue to own a device, their companion(s), and their clinician trainer(s). ReWalk will perform a second round of recruitment through letters to all subjects, companions, and trainers who do not respond to the first request to participate.


ReWalk RWE Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
51 month report 09/13/2020 09/15/2020 On Time
54 month report 12/12/2020 12/14/2020 On Time
57 month report 03/12/2021 03/05/2021 On Time
60 month report 06/10/2021 06/14/2021 On Time
63 month report 09/08/2021   Overdue
66 month report 12/07/2021    


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