Zynex, 6/14

Zynex, 6/14

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Warning Letter noting failure to test all software requirements for a medical device.

Description

Zynex, 6/14

This Warning Letter includes an observation regarding failure to conduct a complete design verification of the software requirements of a multimode electrical stimulator. Verification testing did not include all software requirements. For example, verification testing did not include the control/reset of the treatment timer, idle shut off functionality, and the treatment data storage functionality.

pa document category Warning Letter
Regulation Category Devices – GMP
FDA Office Denver District
System Category Medical Device
Citation Category Validation

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