Explore our medical-grade customized wearables, sensor arrays, kinetic signal generators, and neuro-diagnostic instrumentation available for white-label contract manufacturing.
Precision kinetic neuro-stimulation rod with integrated micro-vibrational feedback. Ideal for motor skill rehabilitation, targeted neuromuscular conditioning, and physical therapy integration.
Medical-grade elastic PP bio-feedback tremor stick configured for dynamic peripheral resonance calibration, core stabilization, and motor neuron sensory training systems.
Closed-loop pneumatic-vacuum and electro-vibrational transducer unit engineered for non-invasive cutaneous nerve stimulation, localized therapy, and tactile modulation.
High-frequency mechanical oscillation bar designed for active peripheral nerve modulation, reflex enhancement, proprioceptive training, and muscular rehabilitation.
Multi-channel signal acquisition unit designed for ultra-low frequency micro-tremor wave monitoring, sub-surface seismic diagnostics, and high-fidelity signal analysis.
Durable synthetic rubber vibration rod designed for dynamic muscle activation, neuromuscular tuning, kinetic kinetic feedback loops, and clinical rehabilitation routines.
Advanced signal processing instrument providing non-destructive micro-tremor velocity testing, continuous spectrum recording, and high-frequency analytical output.
Dismountable flex-harmonic tremor stick engineered for core neuromuscular engagement, proprioceptive feedback tuning, and therapeutic muscle stimulation.
Backed by more than 20 years of neural engineering R&D, our OEM turnkey platform transitions bioelectronic concepts into FDA-cleared, market-ready therapeutics.
We bridge complex neural decoding research with scalable, compliant ISO 13485 contract assembly to deliver customized neuromodulation solutions for global distribution.
Our proprietary cloud neural engine continuously reads electromyographic (EMG) and kinematic signals, decodes individual motor signatures, and adjusts biphasic stimulation waveforms in real time—eliminating static, fixed-dose therapeutic limitations.
Custom PCB-A engineering incorporating sub-millimeter microcontrollers, ultra-low power Bluetooth 5.4 LE SoCs, custom ASIC pulse generators, and skin-conformal multi-array electrode arrays optimized for all-day wearable comfort.
We provide full Design History Files (DHF), Technical Documentation for CE MDR (2017/745), software verification under IEC 62304, and FDA 510(k) Master File submission support for effortless regional market entry.
State-of-the-art Class 8 cleanrooms equipped with high-speed surface-mount technology (SMT), automated optical inspection (AOI), ultrasonic plastic welding, and biocompatible silicone overmolding capabilities.
Customizable biphasic constant-current pulse generator circuits capable of delivering targeted transcutaneous peripheral nerve stimulation (tPNS), vagus nerve modulation (VNS), and high-frequency kinetic vibration therapy.
Turnkey mobile iOS/Android applications paired with secure cloud telemetry dashboards. OEM partners gain real-time patient adherence tracking, battery diagnostics, and over-the-air (OTA) firmware update infrastructure.
The global bioelectronic medicine and neuromodulation device market is undergoing a structural transition. Sourcing managers, MedTech executives, and clinical procurement teams are shifting away from traditional, bulky invasive implantables toward lightweight, non-invasive, AI-assisted therapeutic wearables. To maintain market competitiveness, procurement decision-makers must align with key industry shifts:
Key Insight: Modern neuromodulation procurement has shifted from purchasing simple hardware to acquiring integrated Neuro-AI platforms that combine biocompatible sensors, low-latency firmware, and cloud intelligence.
1. The Rise of Closed-Loop Peripheral Nerve Stimulation (PNS): Conventional neuromodulation devices operated on open-loop, continuous electrical firing. Next-generation OEM procurement focuses heavily on closed-loop systems capable of sensing physiological signatures (such as pathic tremor, spasticity, or autonomic nerve dysregulation) and firing stimulation only when clinically required. This drastically improves battery longevity and therapeutic efficacy while eliminating habituation.
2. Miniaturization and Ergonomic Consumerization: Patients reject non-compliant medical hardware that feels stigmatizing. B2B purchasers are demanding sleek, watch-like wristbands, discreet adhesive patches, and lightweight ergonomic rods. OEM manufacturers must master micro-molding, flexible printed circuit boards (FPCBs), and liquid silicone rubber (LSR) encapsulation to meet these standards.
3. Software-as-a-Medical-Device (SaMD) Integration: Hardware alone no longer commands premium margins. Sourcing partners require OEM platforms backed by compliant mobile applications and cloud analytics capable of parsing biofeedback metrics, tracking session adherence, and generating physician-ready clinical reports.
4. De-Risked Regulatory Supply Chains: Navigating global MDR and FDA clearances presents substantial financial risk. Leading buyers prioritize OEM vendors that offer pre-validated sub-assemblies, ISO 10993 biocompatibility testing packages, and IEC 60601-1-2 EMC testing readiness to cut time-to-market by 50%.
Developing robust bioelectronic wearables demands cross-disciplinary mastery spanning electrical engineering, computational neuroscience, materials science, and medical assembly. Key engineering trends shaping our OEM production lines include:
Detailed technical and commercial answers designed for medical device brands, supply chain directors, and clinical researchers evaluating custom contract manufacturing.
Our turnkey product pipeline operates in five distinct phases: Phase 1: Requirements Definition & Architecture (2-4 weeks); Phase 2: EVT Hardware & Firmware Prototyping (6-10 weeks); Phase 3: DVT Verification & Pre-Clinical Batch Tooling (8-12 weeks); Phase 4: PVT & Regulatory Submissions (IEC 60601-1, ISO 10993) (8-14 weeks); Phase 5: Mass Production Ramp in ISO 13485 Facilities.
We provide clear IP partitioning options. Background IP (our baseline core hardware architectures, sensory processing engines, and cleanroom manufacturing methods) remains licensed to your platform, while Foreground IP (custom exterior industrial designs, proprietary electrode shapes, and application-specific therapy logic) belongs entirely to the OEM buyer upon completion of development milestones.
Yes. While our cleared reference designs target peripheral movement disorders such as essential tremor and Parkinsonian hand tremors, our modular nerve-computer interfaces (Fasikl-X core) can be calibrated for stroke motor recovery, chronic nerve pain management (tPNS), vagal autonomic stimulation, and bio-feedback athletic performance tuning.
We support initial pilot production runs of 500 to 1,000 units for clinical trials and commercial market test launches. Full mass-production volume pricing tiers unlock at 5,000 to 50,000+ units per annum, supported by dedicated automated SMT lines and high-throughput cleanroom packaging.
All internal lithium-polymer and solid-state power systems undergo rigorous IEC 62133 and UN 38.3 transport testing. Device electronics comply with IEC 60601-1 (Basic Safety), IEC 60601-1-2 (EMC), and IEC 60601-1-11 (Home Healthcare Environment compatibility).
Absolute transparency is provided. We provide iOS, Android, and Flutter SDKs alongside RESTful cloud APIs. These tools allow your team to build bespoke clinical portals, connect directly with hospital EHR systems, or integrate custom machine learning models seamlessly.
Accelerate your medical wearable R&D timeline. Speak directly with our senior neural engineering and procurement specialists to request custom technical datasheets, component samples, or a complete OEM proposal.
