MAUDE Adverse Event Report: ZYNEX MEDICAL, INC. NEXWAVE

Model Number	700400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial incident occurred in early 2024, but the patient did not make an initial report to zynex medical, inc.After the incident, the patient disposed of the device and didn't reveal he had an issue until he called zynex medical, inc., on (b)(6) 2026, to discuss the company filing chapter 11 bankruptcy.At that time, a complaint was initiated.
Event or Problem Description
The patient called zynex medical, inc.To discuss the chapter 11 filing on (b)(6) 2026, and when asked how the nexwave device is working, he stated that he hasn't used it since early 2024.The patient then stated that during use of the device, in 2024, he had an adverse reaction to the stimulation, and he fell back and hit his head.The patient went to the hospital for care but did not state the level of care received.The patient had been using the device a couple weeks but does not recall how he was treating himself at the time of the incident.The patient disposed of the device and did not call zynex medical to report the issue at the time of the incident.

• Brand Name: NEXWAVE
• Common Device Name: NEXWAVE
• Manufacturer (Section D): ZYNEX MEDICAL, INC.; 14800 grasslands dr; englewood co CO 80112
• Manufacturer (Section G): ZYNEX MEDICAL, INC.; 14800 grasslands dr; englewood co CO 80112
• Manufacturer Contact: justin harrington ; 14800 grasslands dr; englewood, CO 80112 ; 7204652294
• MDR Report Key: 24211764
• Report Number: 3000214920-2026-00004
• Device Sequence Number: 5430867
• Product Code: LIH
• UDI-Device Identifier: 00852670007007
• UDI-Public: 00852670007007
• Combination Product (Y/N): N
• PMA/510(K) Number: K111279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 700400
• Device Lot Number: 1330318
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Male