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US
Last updated May 24, 2026
What ZYNEX MEDICAL, INC. makes
Zynex Medical, Inc. manufactures transcutaneous electrical stimulation electrodes that are single-use and designed for neuromuscular and nerve stimulation applications. The company also produces physical therapy transcutaneous neuromuscular electrical stimulation systems, analgesic transcutaneous electrical nerve stimulation systems, interferential electrical stimulation systems, transcutaneous incontinence-control electrical stimulators, and wearable multiple physiological parameter recorders that are reusable.
The devices manufactured by Zynex Medical, Inc. are classified as Class II medical devices and are listed in the FDA 510(k) database and the FDA Unique Device Identification (UDI) system. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Zynex Medical, Inc. make?
Zynex Medical, Inc. manufactures transcutaneous electrical stimulation electrodes that are single-use and designed for neuromuscular and nerve stimulation applications. The company also produces physical therapy transcutaneous neuromuscular electrical stimulation systems, analgesic transcutaneous electrical nerve stimulation systems, interferential electrical stimulation systems, transcutaneous incontinence-control electrical stimulators, and wearable multiple physiological parameter recorders that are reusable.
Where is Zynex Medical, Inc. based?
Zynex Medical, Inc. is based in the United States, as stated in the summary section of the device data, which confirms the company's country of origin as US.
Which registries list Zynex Medical, Inc.'s devices?
Zynex Medical, Inc.'s devices are listed in the FDA 510(k) database and the FDA Unique Device Identification (UDI) system, as explicitly noted in the DEVICE CLASSES and LISTED IN fields of the provided data.
How are Zynex Medical, Inc.'s devices classified?
Zynex Medical, Inc.'s devices are classified as Class II medical devices, according to the DEVICE CLASSES field in the data, which specifies this classification without implying any broader company-level approval or certification.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- zynex.com
- —
- —
- [email protected]
- Phone
- 800-495-6670
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 141582226
Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Zynex Medical Electrodes | 300027 | FDA UDI | Class II | Active |
| M-Wave | 701200 | FDA UDI | Class II | Active |
| Zynex Medical Electrodes | 300038 | FDA UDI | Class II | Active |
| E-Wave | 700240 | FDA UDI | Class II | Active |
| Zynex Medical Electrodes | 123019 | FDA UDI | Class II | Active |
| NexWave | 400400 | FDA UDI | Class II | Active |
| InWave | 400410 | FDA UDI | Class II | Active |
| NeuroMove | 400275 | FDA UDI | Class II | Active |
| Zynex Medical Electrodes | 123018 | FDA UDI | Class II | Active |
| TruWave TENS | 400420 | FDA UDI | Class II | Active |
| Zynex Medical Electrodes | 300117 | FDA UDI | Class II | Active |
| CM-1500 Wrist Cuff | 700460 | FDA UDI | Class II | Active |
| Nexwave Combo Muscle Stimulator System | K111279 | FDA 510(k) | Class II | Active |
| M-Wave | K233485 | FDA 510(k) | Class II | Active |
| Zynex Monitoring System, Model CM-1600 | K223217 | FDA 510(k) | Class II | Active |
| Cardiac Monitor 1500 | K191697 | FDA 510(k) | Class II | Active |
| Inwave | K121820 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Zynex Medical, Inc. has one recall record initiated on 2009-01-25, which has been terminated. The recall was initiated because Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances, overheating and becoming hot to the touch.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 25, 2009 | Z-1874-2014 | — | terminated | Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch. |