FDA CDRH 510(k) Powered Muscle Stimulator

“Guidance Document for Powered Muscle Stimulator 510(k)s”

This document was issued on June 9, 1999. This document requires as part of the device description section a description of all user controls, displays and functions.

This guidance references the current FDA software submission guidance, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” and goes on to explicitly require determination of the level of concern, a description of all devices controlled by the software, hazard analyis, software functional requirements, description of the system level test protocol, including pass/fail criteria, and a summary of the test results.

Although the guidance does not specifically state a level of concern and leaves that to the manufacturer, the list of information identified tends to place it at a minor level of concern.

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