Engineered to exact medical-grade specifications, providing reliable solutions for global distributors.
The transition from adult novelties to scientifically backed medical-grade urological recovery devices.
In the contemporary global sexual health landscape, Medical Grade Vacuum Erectile Devices (VEDs)—commonly referred to in commercial markets as medical-grade penis pumps—have evolved from niche lifestyle options to front-line therapeutic interventions. Driven by advancements in non-invasive urological rehabilitation, VEDs are widely prescribed for patients recovering from radical prostatectomy, managing diabetes-related erectile dysfunction, and treating localized Peyronie's disease. By creating controlled negative pressure, these systems stimulate oxygenated blood flow to the corpora cavernosa, facilitating cell viability and reducing cavernous fibrosis.
Globally, the integration of clinical standards into consumer-facing manufacturing is transforming the adult wellness market. Distributing and retailing partners are demanding absolute transparency regarding materials, bio-compatibility, and safety features. As medical guidelines worldwide heavily emphasize non-pharmacological treatments, manufacturers must provide systems that prevent over-pressurization (specifically keeping pressure profiles below the recommended safety limit of 15-20 inHg or ~380-500 mmHg). This paradigm shift requires factories to move away from low-cost plastic assembly toward cleanroom-compliant, FDA-listed, and ISO 13485-monitored manufacturing processes.
Designed for post-prostatectomy penile rehabilitation, preventing cavernous tissue atrophy through controlled active engorgement.
Utilizes exclusively medical-grade polycarbonate and skin-safe, phthalate-free, USP Class VI silicones that prevent irritation.
Integrates auto-release safety valves to maintain therapeutic pressure levels, shielding end-users from barotrauma.
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.
Our state-of-the-art manufacturing base covers an area of 10,000 square meters in Shenzhen. We are recognized as a national and Shenzhen Double High-tech enterprise, certified under strict international regulatory and standards systems including ISO 9001, ISO 13485, BSCI, CE, FCC, ROHS, and FDA registration.
Our main products are Sexual Aid devices, Sexual Health devices, Massage equipment, Personal Health Care appliances, Postpartum Repair equipment, and more. Our integrated supply chain enables seamless execution from raw concept to final shipping.
One-stop solution capability covering industrial design, high-precision molds, and volume production.
We provide our clients with comprehensive, tailored OEM and ODM services. Our robust R&D team consists of veteran Industrial Designers (ID), Mechanical Engineers, Software Engineers, and Electronic Engineers. This multi-disciplinary assembly allows TOPARC to turn complex clinical parameters into marketable, mass-manufacturable health products.
We operate a first-class in-house mold manufacturing center, complete with modern CNC EDM machines and high-speed CNC machining centers. This dedicated engineering department allows us to produce high-precision hardware molds and tooling internally, keeping proprietary brand designs secure while reducing lead times. Our custom plastic injection molding production lines run continuously to output durable shells, while our liquid silicone formation and silicone injection molding lines produce the ultra-soft, body-safe sleeves and gaskets required for reliable airtight seals.
In-house Surface Mount Technology (SMT) and custom motors tailored for silent, high-torque medical application.
Unlike standard adult novelty assemblers, TOPARC features direct SMT (Surface Mount Technology) production lines, enabling us to print, test, and program our own PCBs. This in-house microelectronics capability makes customizing features—such as smart pressure monitoring, digital LCD readouts, auto-timing, and adaptive pressure release controls—completely seamless.
Moreover, we develop and manufacture our own electric motors, optimizing the torque-to-noise ratio. For medical-grade vacuum erectile systems, the motor must supply consistent vacuum draw without high-frequency vibration or disturbing noise. Operating a vertically integrated ecosystem—from SMT and motor production through hardware assembly, wave soldering, and testing—ensures we monitor every component that enters the assembly chain.
How we safeguard B2B distributors through strict validation, certification, and dynamic logistics.
Our facilities are audited under ISO 13485 medical quality management standards, easing FDA registration processes for private labels in North America and CE MDR registration in Europe.
Every batch of vacuum pumps undergoes rigorous testing, including accelerated aging tests, IPX7 waterproof immersion, button tactile life cycle tests, and complete battery profiling.
We assist global partners with localized customs clearance, DDP shipping options, and custom dropshipping setups, reducing storage overheads for domestic medical suppliers.
Innovating vacuum therapy technology through IoT integration, smart sensors, and advanced biocompatibility.
Transitioning from manual mechanical release valves to intelligent micro-processor controlled relief valves. This technology continuously tracks internal pressure to keep the vacuum levels in the cylinder within therapeutic parameters.
Developing Bluetooth-enabled modules for erectile recovery monitoring. Working with clinical researchers to allow users to log pump usage, tracking pressure profiles and duration to share with their doctors.
Replacing traditional brushed motors with ultra-quiet ceramic-bearing brushless micro-pumps. This design reduces operating noise levels to below 30dB while improving suction speed and motor lifespan by over 200%.
Adapting our manufacturing outputs to meet distinct distribution channels and clinical uses.
Used as prescription-grade therapeutic devices under medical supervision. We supply plain, unbranded sterile packaging that fits medical distribution standards.
Designed with customized retail packaging, bespoke colors, and private labeling. We support SMT modification to fit custom programming requirements.
Delivered with compliance labeling (barcode, regulatory declarations, user safety manuals). Ready for brick-and-mortar display hooks.
Answers to crucial regulatory, technical, and commercial questions for professional buyers.
Fully compliant with international standards, offering custom branding and reliable delivery.
TOPARC TOY
