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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 Registry


 
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General
Study Status Revised/Replaced Study
522 Number / Requirement Number PS140001 / PSS001
Date Current Plan Accepted 03/01/2021
Study Name ReWalk Registry
Root Document Number K131798 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description New enrollment long-term, prospective, non- interventional multi-center, observational study
Study Population Description Device group: patients with Spinal Cord Injury and their companions; Comparison group: None.



Sample Size The targeted sample size is 60 subjects (with 60 companions) to be recruited from up to 12 U.S. clinical sites. The sample size is not determined based on a specific hypothesis to be tested since the study is not hypothesis- driven.
Data Collection Long-term safety of the ReWalk Personal Device for Subjects in institutional and non-institutional environments, as measured by 12- month incidence of all Serious Adverse Events in Subjects;

• Long-term safety of the ReWalk Personal Device for Subjects in institutional and non-institutional environments, as measured by 12- month incidence of falls and fall-associated injuries;

• Long-term safety of the ReWalk Personal Device for Companions in institutional and non-institutional environments, as measured by 12- month incidence of all Serious Adverse Events in Companions;

• Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the proportion of Subjects enrolled in training who successfully complete the intended training;

• Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the proportion of Subjects who successfully completed the intended training who are able to demonstrate proficiencies at 12 months after completion of the intended training;

• Adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, as measured by the Subjects’ abilities to navigate surfaces and environments outside of the institutional environment in accordance with their training;

• Adequacy of the Multi-Tiered Training Program of the ReWalk

Personal Device for Companions, as measured by the proportion of

Companions enrolled in training who successfully complete the intended training;
Follow-up Visits and Length of Follow-up Consecutive enrollment at up to 12 US centers

12 months


ReWalk Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 month report 06/06/2016 07/13/2016 Overdue/Received
2 month report 07/05/2016 08/15/2016 Overdue/Received
3 month report 09/15/2016 09/15/2016 On Time
4 month report 10/15/2016 10/12/2016 On Time
5 month report 11/15/2016 11/07/2016 On Time
6 month report 12/15/2016 12/02/2016 On Time
7 month report 01/15/2017 12/29/2016 On Time
8 month report 02/15/2017 01/31/2017 On Time
9 month report 03/15/2017 03/01/2017 On Time
10 month report 04/15/2017 04/03/2017 On Time
11 month report 05/15/2017 05/15/2017 On Time
1 year report 06/15/2017 06/14/2017 On Time
18 month report 12/14/2017 12/18/2017 Overdue/Received
2 year report 06/15/2018 06/15/2018 On Time
3 year report 06/15/2019 06/04/2019 On Time


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