A trusted manufacturing powerhouse for sexual aids and medical-grade recovery devices since 2008.
TOPARC TECHNOLOGY (SHENZHEN) CO., LTD. was established in July 2008 with a registered capital of HK$18 million. It is a modern Hong Kong-funded enterprise integrating the research and development, production, sales, and service of sexual aids and sexual health products. Over the past 16 years, we have positioned ourselves as a leading global supplier of personal health appliances and pelvic rehabilitation technologies.
Our state-of-the-art manufacturing base covers an area of 10,000 square meters in Shenzhen, the tech capital of China. We are proud to hold certifications as both a national and Shenzhen Double High-tech enterprise. To guarantee the highest standards of safety, quality, and efficacy for medical and retail markets, our facilities are strictly audited and conform to ISO 9001, ISO 13485 (Medical Devices Quality Management System), BSCI, CE, FCC, RoHS, and FDA specifications.
Our main product portfolio includes Sexual Aid devices, Sexual Health devices, Massage equipment, Personal Health Care appliances, and Postpartum Repair equipment. By integrating advanced urological mechanics and anatomical studies, our medical penis pumps serve as clinical-grade solutions for post-prostatectomy therapy, erectile dysfunction (ED) rehabilitation, and proactive intimate wellness.
Understanding the demands of medical device distributors, OTC brands, and sexual healthcare providers.
Global brands require absolute material safety. We utilize USP Class VI medical-grade silicones and high-impact polycarbonate cylinders that are 100% biocompatible, phthalate-free, and hyper-allergenic, preventing dermal irritation.
Medical compliance mandates strict limitations on maximum negative pressure. Our systems feature precision-engineered manual and automated release valves to ensure pressure never exceeds FDA recommended safety limits (250-350 mmHg).
We provide full batch traceability and cleanroom assembly workflows required for medical-grade items, lowering registration friction with the FDA, EMA, and other international regulators.
From product concept to high-precision hardware molds, we offer a comprehensive one-stop OEM/ODM pipeline.
We provide our clients with end-to-end OEM and ODM services. Our robust in-house R&D team comprises industrial designers (ID), mechanical engineers, software engineers, and electronic engineers. Equipped to turn concept sketches into fully functional therapeutic devices, we maintain a first-class mold manufacturing center utilizing high-precision CNC EDM machines and CNC machining centers.
This state-of-the-art tooling infrastructure enables us to design and engineer durable high-quality hardware, injection shells, and medical accessory components entirely in-house. Our automated plastic injection molding production lines produce the structural out-shells of our sexual health devices, massage equipment, and medical pumps. Simultaneously, our high-volume liquid silicone rubber (LSR) injection molding lines manufacture bio-friendly gaskets, sleeves, and pelvic floor muscle repair assets.
Pioneering active pressure monitoring, smart connectivity, and proprietary high-torque silent motors.
At TOPARC, we integrate SMT (Surface Mount Technology) assembly capabilities directly within our facility, enabling us to design, prototype, and manufacture custom Printed Circuit Boards (PCBs) in-house. This gives our OEM clients the power to introduce custom software logic, including LED/OLED readouts, digital vacuum pressure sensors, auto-inflation cycles, and biological feedback tracking.
Our engineering depth also features self-developed motor technologies. We produce high-performance, medical-grade vacuum micro-pumps that generate deep, stable suction while maintaining exceptionally low decibel footprints (under 48dB). Backed by 16 years of assembly experience, our processing workflows encompass hardware milling, electronic soldering, post-soldering refinements, functional testing, and final cleanroom assembly.
We customize microcontroller functionalities to support multi-stage pressure programs, Bluetooth application pairing, and child-lock electronic safety valves.
Our custom brushless DC motors operate with low vibration, extending battery lifespan while outputting stable vacuum pressure for clinical therapy.
From initial solder paste application to plastic heat-staking and ultrasonic sealing, every process is conducted under one roof to maintain top efficiency.
How our geographic positioning in Shenzhen, China optimizes B2B margins and shortens market lead times.
Shenzhen houses the world’s most dense cluster of industrial component suppliers. Within a 30-minute radius, we secure premium food-contact-approved plastics, electronic sensors, high-grade liquid silicones, and custom packaging, greatly minimizing inbound logistics latency.
With in-house CNC centers and SMT capabilities, we turn design adjustments into physical samples in days, rather than weeks. This allows global consumer health brands to quickly pivot, modify features, and finalize designs before competitor tooling begins.
By automating key injection molding processes and optimizing our logistics hubs near Shenzhen Port, we pass substantial cost savings down to you. We offer premium, compliant medical-grade manufacturing at a fraction of the cost of Western fabricators.
De-risking international import hurdles through validated certification packages and localization support.
Medical devices like vacuum erection devices (VEDs) fall under Class II regulatory frameworks in the United States (FDA) and Class Im/IIa frameworks in the European Union (CE MDR). Importing medical items requires strict adherence to raw material trace sheets, biocompatibility testing (ISO 10993), and risk assessments.
As an ISO 13485-certified manufacturer, TOPARC provides our distributors with complete documentation kits, including Material Safety Data Sheets (MSDS), RoHS compliance declarations, and test metrics to support your FDA 510(k) applications or local health authority registrations.
Additionally, we assist in localizing your products for specific target markets. From multi-language user manuals and customized retail packaging to region-specific power cables (UL, CE, UKCA plug variants) and regulatory graphics, we align every detail with local laws.
Keeping your product lines ahead of the curve with cutting-edge medical trends and clinical applications.
Clinical studies show that early use of Vacuum Erectile Devices (VEDs) post-prostate surgery prevents tissue atrophy and accelerates natural erectile recovery by promoting localized oxygenated blood flow.
Modern patients seek tracking apps. We specialize in building low-energy Bluetooth (BLE) modules that link to mobile apps, enabling users to log therapy times, pressures, and recovery progress privately.
The industry is transitioning toward ultra-soft, dual-durometer silicone rings. These rings offer a hermetic seal against the skin, ensuring maximum comfort and preventing bruising during vacuum cycles.
As global health markets lean toward telemedicine and remote patient monitoring, medical penis pumps are evolving into smart home-care systems. At TOPARC, our engineering teams are actively designing next-generation digital pumps with automatic safety limits.
By integrating smart pressure transducers and micro-controllers, our devices monitor tissue resistance and auto-adjust target negative pressures. This prevents excessive tension, guarantees safety, and delivers a superior clinical outcome compared to traditional manual hand-pump cylinders.
Every product undergoes extensive testing to guarantee performance, longevity, and clinical safety.
We deeply understand the critical nature of product testing. Our localized laboratory houses 22 specialized testing instruments dedicated to validating mechanical and electronic components across the entire production lifecycle.
Our QA testing protocols include:
We execute 100% functional testing on all finished goods before they leave our factory doors. This guarantees that your brand is protected against high return rates, product recalls, or functional failures. Partnering with TOPARC TECHNOLOGY ensures you get competitive pricing, premium quality control, and scalable production capability.
Important questions regarding medical penis pump compliance, sourcing, and OEM capabilities.
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