Transcutaneous Nerve Stimulation

B2B transcutaneous nerve stimulation (TENS) hardware. Engineered with asymmetrical biphasic waveform synthesis and constant-current regulation to target A-beta fibers without epidermal thermal burns.

Transcutaneous Nerve Stimulation (TENS) hardware functions as a clinical-grade pulse generator designed to modulate the human nervous system via non-invasive surface electrodes. The primary engineering objective is to drive controlled electrical vectors across the high-impedance stratum corneum (epidermis) to depolarize underlying sensory nerve fibers. By synthesizing specific electrical frequencies and pulse widths, the hardware mathematically triggers the Gate Control mechanism at the spinal dorsal horn. We manufacture and supply these foundational PCBA architectures and finished stimulators to physical therapy brands, digital health OEMs, and medical device procurement networks globally.

The PCBA is built around a central microcontroller (MCU) that governs waveform generation. Because human skin acts as a variable resistor, the hardware utilizes a step-up transformer circuit paired with an active feedback loop. The MCU continuously monitors transdermal impedance. If resistance drops, the voltage rail is instantly throttled down to maintain the precise milliampere (mA) set by the clinician. The output is strictly formatted as an asymmetrical biphasic square wave, preventing galvanic ion buildup at the electrode site. Standard clinical models operate on a DC 3.7V or 9V architecture. Tooling and PCBA customization require an MOQ of 2,000 units.

• Asymmetrical Biphasic Waveform Synthesis 

  Passing a continuous monophasic current through human tissue causes a rapid electrochemical polarization, driving acid or alkaline buildup under the electrode pads. This results in severe galvanic burns within 15 minutes. The MCU in this hardware synthesizes an asymmetrical biphasic wave. The initial pulse delivers the necessary therapeutic energy (depolarization), while the secondary reverse phase mathematically cancels out the residual charge. This zero-net-DC-charge execution allows for continuous 60-minute pain management sessions without altering the epidermal pH or causing chemical tissue damage.

   

• Constant-Current Impedance Compensation 

  During a therapy session, biological factors-such as localized sweat (diaphoresis) or increased blood flow-drastically reduce the electrical resistance of the skin. In a primitive voltage-based machine, a drop in resistance causes a mathematically proportional, violent spike in current (Ohm's Law), shocking the patient. This PCBA employs a high-speed constant-current regulator. As skin impedance drops, the feedback circuit instructs the MCU to drop the output voltage proportionately within milliseconds, maintaining a mathematically flat, uninterrupted current delivery.

   

• A-Beta Nerve Fiber Targeting (Gate Control) 

  Effective transcutaneous stimulation requires precise targeting of the large, myelinated A-beta nerve fibers while avoiding the motor neurons that cause muscle spasms. The hardware strictly caps the pulse width parameters between 50μs and 100μs for acute pain modes. Combined with an 80-120Hz high-frequency output, this specific electrical vector floods the dorsal horn of the spinal cord with non-painful sensory data, physically closing the neural "gate" to slower, C-fiber chronic pain signals. 

• Parameter Lockdown (Rx vs. OTC) : We modify the MCU firmware to lock specific parameter ceilings. For clinical Prescription (Rx) units, the output can be pushed to 120mA. For Retail (OTC) units, the firmware is hard-coded with a 100mA limiter and mandatory automatic shut-off timers to comply with specific regional regulatory guardrails. 

• Logistics Routing : Bare-board PCBA SMT placement, transformer winding, and testing operate in our China facility. Final enclosure assembly, calibration, QA sorting, and barrier-kitting route through our Vietnam hub to manage supply chain continuity and optimize medical electronics tariffs globally.

• Regulatory Support : Complete PCB layouts, software validation matrices, and electrical safety schematics support B2B clients in filing for FDA 510(k) Class II and CE (MDR) market clearance. 

• Systems : Component soldering, active waveform oscilloscope validation, and final assembly are executed within audited ISO 13485:2016 and MDSAP regulatory frameworks.

B2B clinical distributors and medical device OEMs can request PCBA architecture files and active waveform oscilloscope reports. 

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