FDA WARNING_LETTER - Zynex Medical, Inc. - January 21, 2014

An FDA inspection of Zynex Medical, Inc. from January 6-21, 2014, revealed that their NexWave and IF8000 electrical stimulators are adulterated under section 501(h) of the Act, failing to conform with Quality System regulation (21 CFR Part 820). Key violations include inadequate procedures for complaint handling (21 CFR 820.198(a)), design inputs (21 CFR 820.30(c)), design verification (21 CFR 820.30(f)), and corrective and preventive actions (21 CFR 820.100(a)). The firm also failed to establish a device master record (21 CFR 820.181), maintain complete device history records (21 CFR 820.184), and conduct scheduled internal audits (21 CFR 820.22). Additionally, devices were misbranded under section 502(t)(2) due to failures in Medical Device Reporting (21 CFR Part 803), specifically not reporting device malfunctions and inadequate MDR procedures. A significant violation involved the failure to report a 2009 recall for the IF8000 electrical stimulator as required by 21 CFR 806.10. The firm's responses to the FDA 483 were deemed inadequate, lacking sufficient documentation or comprehensive corrective action plans. Zynex Medical must promptly correct these violations within fifteen business days, provide documentation of systemic corrections, and a timetable for completion to avoid further regulatory actions such as seizure, injunction, civil penalties, and impacts on future device approvals or government contracts.