FDA EIR - Zynex Medical, Inc - June 15, 2022

FDA EIR for Zynex Medical, Inc on June 15, 2022. Product: devices. Access full analysis and detailed observations.

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Record Summary

FDA EIR for Zynex Medical, Inc on June 15, 2022. Product: devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 CFR 820.50(a)

21 CFR 820.198

21 CFR 820.30

21 CFR 820.100(a)

21 CFR 820

21 CFR 820.90(b)(2)

21 CFR 820.80(b)

21 CFR 820.100(a)(4)

21 CFR 820.100(b)

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Record Information

Company

Zynex Medical, Inc

Inspection Date

June 15, 2022

Product Type

devices

Office

Office of Medical Device and Radiological Health Operations, Division 3 – West

People

ID: d54371ec-d9cc-4539-8528-619a0c54126d

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