Product Overview
Medical Wearable Solutions encompass custom-engineered, clinical-grade hardware platforms built for remote patient monitoring (RPM), continuous physiological telemetry, and decentralized clinical trials. Operating as a professional contract manufacturer, we transform client specifications into production-ready medical hardware, managing the entire pathway from initial schematic review to volume cleanroom assembly.
Our engineering framework integrates ultra-low-power microcontrollers, high-precision sensor nodes, and biocompatible enclosures. Every device undergoes rigorous signal-integrity verification and environmental stress testing prior to commercial release, mitigating regulatory friction and reducing time-to-market for digital health brands.
-
![PP Reinforced Fixation Patch]()
PP Reinforced Fixation PatchProduct Name: PP Reinforced Fixation Patch. Specifications: Customizable. This product uses medical-grade non-woven fabric or PU film as the base material, with a locally reinforced polypropylene -
![Adhesive-backed SpO2 Probe Fixation Pads]()
Adhesive-backed SpO2 Probe Fixation PadsProduct Name: Adhesive-Backed Pulse Oxygen Probe Fixation Patch (Disposable Medical Grade). Our Adhesive-Backed Pulse Oxygen Probe Fixation Patch is a specialized medical accessory designed to -
![Continuous Glucose Monitor Fixation Patch]()
Continuous Glucose Monitor Fixation PatchProduct Name: Continuous Glucose Meter Reinforcing Patch. Specifications: Customizable. This product uses medical-grade polyurethane (PU) film or non-woven fabric as the base material, coated with -
![Self-heating Moxibustion Patch]()
Self-heating Moxibustion PatchProduct Name: Self-Heating Moxibustion Patch . Our Self-Heating Moxibustion Patch is an innovative thermal delivery system designed to combine traditional Chinese moxibustion therapy with modern -
![Catheter Fixation Patch]()
Catheter Fixation PatchProduct Name: Catheter Fixation Dressing. Specifications: Customizable. This product uses medical-grade polyurethane (PU) film or non-woven fabric as the base material, featuring a composite catheter -
![Chest Seal Patch]()
Chest Seal PatchProduct Name: Chest Sealing Patch. Specifications: Customizable. This product uses medical-grade polyurethane (PU) film or hypoallergenic non-woven fabric as the base material, with a composite -
![Skin Stapler Adhesive Pads]()
Skin Stapler Adhesive PadsProduct Name: Skin Suture Patch. Specifications: Customizable. This product uses medical-grade non-woven fabric or polyurethane (PU) film as the base material, with a composite snap-lock or zipper -
![Skin-toned Stretch Cloth]()
Skin-toned Stretch ClothProduct Profile: High-Performance Skin-Colored Elastic Fabric Single-Sided Adhesive. Our Skin-Colored Elastic Fabric Single-Sided Adhesive Tape is a premium medical-grade fixation solution engineered -
![Medical Wound Dressing]()
Medical Wound DressingProduct Name: Medical Dressing. Specifications: Customizable. This product uses medical-grade non-woven fabric or polyurethane (PU) film as the base material, composited with an absorbent core -
![Silicone Gel Patch]()
Silicone Gel PatchMedical Silicone Gel Patches – Precision Manufacturing & Therapeutic Excellence. As a specialized manufacturer in advanced wound care and scar management, we dedicate our facilities to the -
![Medical Waterproof Patch]()
Medical Waterproof PatchProduct Name: Medical Waterproof Dressing. Specifications: Customizable. This product uses medical-grade polyurethane (PU) film, PE film, or high-transparency medical pressure-sensitive adhesive tape -
![Medical Breathable Fixation Patch]()
Medical Breathable Fixation PatchProduct Name: Medical Breathable Fixation Adhesive. Specifications: Customizable. This product uses medical-grade non-woven fabric, elastic fabric, or high-permeability polyurethane (PU) film as the
Construction & Materials
Device reliability depends on precise material selection and mechanical stack-up engineering. Our standard construction model utilizes a three-tier architecture:
Skin-Contact Layer: Hypoallergenic, breathable medical-grade polyurethane (PU) films or non-woven hydrocolloid adhesives sourced from qualified medical compounders. Adhesives feature skin-friendly tack profiles verified for zero cytotoxicity and sensitization under ISO 10993-5 and ISO 10993-10.
Enclosure & Housing: Ultrasonic-welded ABS/PC blends or medical-grade silicone elastomers. Enclosures provide ingress protection up to IP67, ensuring fluid resistance during routine patient hygiene and clinical disinfection.
Internal Substrate: Flexible printed circuits (FPCs) and rigid-flex PCB configurations plated with immersion gold (ENIG) to prevent trace oxidation under high-humidity physiological conditions.
Functional Performance
Performance metrics define clinical utility and battery autonomy in continuous monitoring deployments:
Signal Acquisition:
Multi-channel analog front-ends (AFE) support high-resolution ECG (up to 500 Hz sampling rate, < 10 uVpp noise floor) and photoplethysmography (PPG) optical tracking.
Wireless Connectivity:
Integrated Bluetooth Low Energy (BLE 5.3) modules ensure reliable data transmission within a 10-meter line-of-sight range while maintaining peak currents under 5 mA during transmission bursts.
Power Management:
Rechargeable lithium-polymer cells or primary zinc-air batteries deliver continuous operation ranging from 72 hours (active telemetry) to 14 days (intermittent logging) per charge cycle.
Wear Duration:
Ergonomic, low-profile mechanical designs distribute weight evenly (< 15 grams total device mass), preventing mechanical peel forces during patient movement and supporting multi-day continuous wear protocols.
Biocompatible Skin Interface: Zero-latex, hypoallergenic adhesive layers prevent contact dermatitis during extended multi-day wear cycles.
Rigid-Flex PCB Architecture: Conforms to anatomical contours, absorbing mechanical stress and preventing solder joint fatigue during patient bending or rotation.
Hermetic Sealing: Laser-welded and ultrasonically sealed enclosures protect sensitive internal sensors from sweat, saline, and clinical cleaning agents.
Modular Sensor Integration: Scalable bus architecture allows rapid integration of temperature sensors, 3-axis accelerometers, and optical modules without redesigning the mainboard.
Secure Firmware Bootloader: Cryptographic hardware roots of trust support secure OTA (Over-The-Air) firmware updates adhering to strict medical data-encryption standards.
Technical Specifications
|
Specification Parameter |
Standard Metric / Value |
Test Standard / Condition |
|
Operating Voltage |
1.8V - 3.6V DC (Regulated LDO) |
Ambient Temp 25 C |
|
Ingress Protection |
IP67 (Dust-tight, immersion up to 1 meter) |
IEC 60529 |
|
Biocompatibility |
Cytotoxicity (Pass), Sensitization (Pass), Irritation (Pass) |
ISO 10993-5, -10, -23 |
|
Wireless Protocol |
Bluetooth 5.3 Low Energy (BLE) |
FCC Part 15 / ETSI EN 300 328 |
|
Operating Temperature |
+5 C to +40 C (Skin contact limit) |
IEC 60601-1 |
|
Battery Life |
Up to 168 hours (continuous logging mode) |
120 mAh Li-Po Cell |
|
Dimensions (Patch Style) |
45 mm x 25 mm x 8.5 mm (Typical) |
Customizable per project |
|
Mass / Weight |
< 14 grams (including battery and adhesive) |
Analytical balance measurement |
Applications
Lorem ipsum dolor sit amet consectetur adipisicing elit
Remote Patient Monitoring (RPM):
Long-term outpatient tracking of cardiac arrhythmias, hypertension, and post-discharge recovery metrics.
Decentralized Clinical Trials:
Continuous physiological data collection in real-world patient environments to evaluate drug efficacy and safety profiles.
Sleep Medicine:
Ambulatory monitoring of nocturnal oxygen saturation, respiratory effort, and autonomic nervous system activity.
Occupational Health & Safety:
Real-time physiological stress and core temperature monitoring for workers in high-temperature or hazardous industrial environments.
We provide end-to-end engineering customization matching clinical and industrial requirements:
Form Factor & Mechanical Customization: Custom enclosure geometry, tailored adhesive pad shapes, and specific color/branding finishes.
Hardware Adaptation: Modification of sensor suites (adding EDA/GSR, bio-impedance, or optical modules) and custom FPC layout design.
Firmware & Software Development: Board support package (BSP) development, custom BLE profile implementation, and secure API documentation for mobile app integration.
Prototyping & DHF Generation: Rapid CNC/SLA prototyping within 15 business days, accompanied by complete Design History File (DHF) documentation packages for regulatory submissions.
Manufacturing & Quality Control
Production execution takes place inside controlled manufacturing environments:
Cleanroom Assembly:
ISO Class 7 (Class 10,000) cleanrooms equipped with automated pick-and-place lines, precision dispensing robots, and automated optical inspection (AOI) systems.
In-Process Quality Control (IPQC):
100% electrical testing of assembled PCBs, automated seal-integrity leak testing, and laser-marking traceability with unique device identification (UDI) barcodes.
Environmental Stress Screening (ESS):
Batch samples undergo thermal cycling (-20 C to +60 C) and vibration testing to eliminate infant mortality defects prior to final sterile or clean packaging.
Quality & Compliance
Quality Management System: Maintained under ISO 13485 certification standards for medical device manufacturing.
Regulatory Alignment: Manufacturing processes and documentation frameworks structured to support standard FDA 510(k) clearance and CE MDR compliance pathways.
Traceability: Full raw material lot traceability maintained via enterprise resource planning (ERP) systems, tracking every component from supplier batch to final shipped serial number.
FAQ
We're well-known as one of the leading medical wearable devices manufacturers and suppliers in China. We warmly welcome you to wholesale high quality medical wearable devices made in China here from our factory. If you have any enquiry about customized service, please feel free to email us.
