Model note · TENS
Zynex NexWave
The NexWave is a prescription, two channel portable electrotherapy unit that combines interferential current (IFC), TENS and NMES in one handheld device for clinic or home use. It is used for symptomatic relief of chronic, post traumatic and post surgical pain and for muscle re education and atrophy prevention. It runs on a 9 V battery or a 12 V medical power supply and records usage with a built in compliance meter.
The model
Maker, model and type.
- Maker
- Zynex Medical, Inc.
- Model
- NexWave
- Device type
- TENS
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| IFC | 0 to 50 mA; channel 1 at 4000 Hz, channel 2 at 4001 to 4128 Hz; symmetrical biphasic | Source |
| TENS | 0 to 100 mA, 1 to 125 Hz, 120 to 300 microsecond pulses; sweep and modulation modes | Source |
| NMES | 0 to 100 mA, 35 Hz, 480 microsecond pulses; 10 s on with 10, 20 or 30 s off; ramp up 3 s, down 1 s | Source |
| Maximum output | Constant current; up to 100 V peak and 100 mA peak into 1000 ohm | Source |
| Treatment timer and compliance | 10 to 90 min in 10 min steps or no timer; meter records total minutes and number of uses | Source |
| Power | One 9 V alkaline battery (MN1604, P/N 130010) or 12 VDC medical power supply P/N 200109 (100 to 240 VAC input) | Source |
| Size and weight | 2.9 x 4.6 x 1.0 in; 5.8 oz with battery | Source |
| Lead wires | 104203 black with black pins; 104204 grey with red pins | Source |
| Classification | Type BF applied parts; operating 0 to 40 C; EU Class IIa | Source |
| FDA clearance | K111279, 21 CFR 890.5850, Class II, product codes IPF, GZJ, LIH; cleared 20 September 2011, prescription use | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- Contraindicated with cardiac demand pacemakers, and electrodes must not be placed over the carotid sinus or across the head. Source
- Do not use for pain syndromes that have not been diagnosed. Source
- Connecting a patient to high frequency surgical equipment at the same time can cause burns under the stimulator electrodes. Source
- Output can exceed 2 mA rms/cm2 current density; keep below 0.5 W/cm2 with the recommended electrodes. Source
- Use caution with heart disease, epilepsy, bleeding risk after trauma, recent surgery and areas lacking sensation; safety in pregnancy is not established. Source
- On mains power there is no isolating switch; unplug the adapter to disconnect fully. Source
Sources
Where this note comes from.
- Zynex NexWave User's Manual P/N 300400 Rev 11.0 (archived copy of zynex.com PDF)
- FDA 510(k) K111279, NexWave combination stimulator
- openFDA MAUDE problem counts, NexWave
- openFDA recall search, NexWave (no matches)
Not covered: The live manual link on zynex.com now redirects to another domain that refused access, so an archived May 2024 copy was used. No FDA recalls were found and MAUDE has only six reports, so failing parts evidence is minimal. There is no service manual or internal error code list in public view.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.