Xiamen Huakang Orthopedic Co.,Ltd

OEM & ODM manufacturer with MDR CE, FDA

About Us

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Type of business OEM & ODM manufacturer, factory
Main Market Europe, the United States, Asia
Brand Huakang Ortho
Number of Employees 101-200 People
Annual sales US$10 Million - US$50 Million
Established in 2014

Founded in 2014 in Xiamen, China, Huakang Orthopedic started with a single focus: build orthopedic braces that distributors and clinicians can trust — on performance, on compliance, and on delivery.

A decade later, we supply rehabilitation braces to 30+ countries across Europe, North America, and Southeast Asia, with annual revenue exceeding USD 10 million. Every product leaves our factory backed by MDR CE, FDA, and ISO 13485 certification — not as a checkbox, but as a commitment.

What We Make

Our product range covers the full spectrum of orthopedic rehabilitation support: Knee Braces (OA unloader, ROM hinged, post-op, sport), Ankle & Foot Orthoses (AFO, air walker boots, night splints), Back Supports (LSO, TLSO, lumbar, posture correctors), Upper Limb supports (elbow, wrist, shoulder slings, cervical collars), and Pediatric Braces designed specifically for younger patients.

Why Distributors Choose Huakang

Certified for your market. MDR CE, FDA, and ISO 13485 — our certifications cover our core product range, so you can sell into Europe and North America without re-qualification delays.

Built for OEM & ODM. Whether you need your logo on an existing product or a completely custom design from scratch, our R&D team handles the engineering. MOQs are flexible to suit both scaling brands and established distributors.

Batch traceability, start to finish. Every order is tracked by unique lot number from raw material receipt through to final shipment — full documentation for your compliance needs.

A quality contact, not a ticketing queue. You get a dedicated quality contact for technical questions, complaints, or audit requests. We use the 8D problem-solving method and notify customers before any product or process change.

Trusted by Leading Brands

Our products are distributed through medical device companies, orthopedic brands, and national distributors — including partnerships with recognized names in the US market. We welcome prospective customers to request references or arrange a factory audit at any time.


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