About Us

Shenzhen Changkun Technology Co., Ltd. (Brand: CHANGKUN / CK) was founded in 2009 and is based in Shenzhen, China. We are an original manufacturer specializing in home health monitoring and maternal rehabilitation medical devices. Our business covers in-house R&D, mold development, automated production, global sales and technical support. For more than a decade, we have focused on home medical hardware development, with the United States as our core target market. We supply reliable, regulation-compliant home healthcare products for North American B2B clients and have built a solid reputation as a trusted ODM & OEM manufacturer of home medical devices..

Our product lineup includes digital blood pressure monitors, infrared forehead thermometers, finger pulse oximeters, electric breast pumps and pelvic floor trainers. Our products serve two major scenarios: daily home health tracking and postpartum rehabilitation care. We offer upper-arm & wrist blood pressure monitors, voice-enabled blood pressure monitors, non-contact infrared thermometers, portable pulse oximeters, dual electric breast pumps and compact pelvic floor trainers. English UI, voice prompts and user manuals are available to meet US consumer habits and FDA labeling requirements..

Innovation drives Changkun’s continuous growth. We operate our own R&D center with hardware engineers, embedded firmware developers, structural designers, algorithm specialists and reliability testers. Our team focuses on biosensor technology, physiological signal acquisition, high-precision measurement algorithms, motor control and ergonomic design. We manage the full development cycle: concept evaluation, schematic design, PCB layout, firmware programming, mold prototyping, performance verification and accuracy calibration.

We hold a portfolio of utility patents, design patents and software copyrights. We keep improving measurement accuracy, battery life, noise reduction, wearing comfort and user experience. Beyond standard off-the-shelf items, we help US brand owners turn market ideas into mass-producible, FDA-compliant products. Feature adjustment, ID redesign, Bluetooth APP integration and custom packaging with English labeling can all be customized as requested.

Changkun runs standardized medical device production workshops equipped with SMT production lines, assembly stations, aging test benches, precision calibration labs, final inspection zones and warehouses. The whole site is managed by lean zoning rules. All manufacturing activities follow the ISO13485 medical quality management system. We maintain a full quality control workflow: incoming material IQC, in-process IPQC, finished goods FQC and pre-shipment OQC.

Every batch of components is sampled and inspected before production. Semi-finished products go through power aging and accuracy recheck. Finished units pass strict reliability tests including function verification, precision testing, battery durability, drop test and temperature cycling. For blood pressure monitors, oximeters and thermometers, we regularly calibrate reference equipment to minimize measurement errors and ensure consistent batch quality. We fully recognize that the US market enforces extremely strict standards for safety, accuracy and failure rate, so quality discipline is embedded in every production step.

The United States is our primary market. Our team is deeply familiar with US medical device regulatory frameworks. Our products support FDA registration and 510(k) clearance under the ISO13485 quality system, which allows legal import into the US market. Our products are ready for US pharmacies, retail chains, Amazon and independent brand websites.

We are experienced with US regulatory details: FDA registration renewal, labeling rules, English user manual requirements, warning statements, traceability, UPC setup and Amazon medical category approval. At the early stage of each project, we identify compliance risks and assist buyers with FDA documentation, test reports, label revision and manual review. This greatly reduces compliance hurdles for US importers and brand owners and is one of our core competitive advantages.

We provide three flexible cooperation models for US partners at different stages:

1.Ready Stock Wholesale: Mature SKUs are kept in stock. We support small trial orders and full-container bulk shipments with stable lead time, ideal for US importers, distributors, Amazon sellers, local pharmacies and health retail chains.

2.ODM Private Label: Based on our proven hardware and firmware platform, you can customize housing, color, silk print, packaging and brand logo to launch your private label quickly with lower cost and shorter lead time.

3.Custom OEM Development: Complete new product development from scratch. We define specifications, functions, appearance and software according to your requirements and develop new tooling. This option suits US brands that want unique flagship products.

CHANGKUN products are exported to North America, Europe and other overseas regions. The United States is our highest-priority market. We maintain long-term partnerships with US medical importers, regional distributors, pharmacy chains, DTC brands and Amazon sellers. We have solid knowledge of local consumer preferences, channel rules, pricing strategies, after-sales protocols and product recall risk control in the US.

We continuously collect feedback from the North American market to guide product iteration. Our products, packaging and marketing materials are optimized to fit US local demands. More than a simple factory supplier, we position ourselves as your long-term supply chain partner to grow together in the US home healthcare industry.

Our Mission: Bring professional health monitoring and rehabilitation care to families across the United States and worldwide with reliable home medical technology.

Our Vision: To be the preferred ODM & OEM manufacturing partner of home medical devices for US buyers.

Our Core Values: Quality First, Integrity for Win-Win, Continuous Innovation, Responsibility for Health.

At Changkun, we understand that medical products represent trust. The US market sets rigorous safety standards for healthcare devices. We refuse to cut corners for ultra-low pricing. We keep balancing quality, cost and compliance, and look forward to building stable, mutually beneficial partnerships with US importers, brands and distributors.

✅ Over 16 years of home medical device R&D and manufacturing experience, direct factory

✅ ISO13485 certified, products support FDA registration and 510(k) clearance for US market access

✅ In-house hardware & software R&D team for algorithm, structure and firmware customization

✅ Multi-stage strict QC system to guarantee stable accuracy and consistent batch quality

✅ Flexible options: ready stock, ODM private labeling and full OEM development

✅ Strong US regulatory expertise: support FDA documents, labeling review and Amazon category preparation

✅ Localized customization for English UI, voice prompts, manuals and packaging

✅ Responsive B2B team, reliable lead time and dedicated after-sales technical support