What certifications does the product have?

The product is certified with CE and FDA standards, and the manufacturer operates under an ISO13485 quality management system.

What is the minimum order quantity (MOQ)?

The minimum order quantity is 1000 pieces.

What is the lead time for production?

The average lead time is one month, applicable for both peak and off-season periods.

Adjustable Wrist Hand Splint with CE and FDA

Name: Adjustable Wrist Hand Splint with CE and FDA
Brand: Xiamen Huakang Orthopedic Co., Ltd.
SKU: 2018539705

Fujian, ChinaXiamen Huakang Orthopedic Co., Ltd.

US$5.50-9.90

300 Pieces

Product profile

Customization

Available

Customized

ODM&OEM

Certification

ISO, CE, FDA

Model NO.

WS006

Condition

New

Usage

Fracture Fixation

Using Site

Wrist

Type

External Fixator

Logo

as Your Request

Lead Time

45 Days

Materials

Aluminum Strip; Hook-Loop

Transport Package

1 Polybag/PC or Customized Box

Trademark

Huakang Ortho

Origin

Xiamen, China

HS Code

9021100090

Key features

CE and FDA Certified: Products comply with CE and FDA standards for safety and quality assurance.

Adjustable Fixation Angle: Built-in metal support bar allows adjustable wrist joint fixation angle as needed.

Customizable Logo and Material: Logo and materials (Aluminum Strip, Hook-Loop) can be customized per request.

OEM and ODM Service: Supports OEM and ODM manufacturing with low MOQ for custom designs.

Multi-Strap Stability: Multiple straps and Velcro design increase stability and ease of adjustment.

Versatile Medical Usage: Suitable for fracture fixation, sprains, carpal tunnel, and osteoarthritis.

ISO13485 Quality System: Manufacturer holds ISO13485 certification for rigorous quality management.

100% Finished Product Inspection: Strict QA/QC with 100% visual inspection of finished products.

Company profile

Importers and ExportersYears of Export ExperienceSelf-brandedManagement Certification

Xiamen Huakang Orthopedic Co., Ltd.

Fujian, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 10 Years CertifiedNearest Port: Xiamen PortAverage Response Time: ≤6.76h

AI-Powered supplier vetting

SummaryThe supplier is a limited company with 122 employees, an effective import/export license, and business activities covering medical equipment, textiles, suitcases, and sporting goods. It reports broad customization, 3D software design, ODM, and OEM capabilities, but no new products in the past year and no available SDK. Quality and complaint-handling procedures are documented and followed, with corrective and preventive action procedures in place. The supplier has inventory capability and has exported for 10 years, while peak- and off-season lead times are each stated as one month. It lacks valid manufacturing-capacity contracts with related subcontractors, overseas warehouses, overseas showrooms, and overseas agents or branches. Evidence of certifications, financial strength, and specific customer cases is insufficient.

Supplier typeThe supplier is identified as a limited company rather than an offshore entity or larger company-group member. Its stated business scope includes manufacturing medical equipment, textile products, suitcases, and sporting goods, indicating a combined manufacturing and trading-related operating profile.

After-Sales capabilityThe supplier has clear, followed procedures for customer complaints and corrective and preventive actions, supporting a defined after-sales issue-management process. However, it has no overseas agents or branches, overseas warehouse, or overseas showroom, which limits documented local service infrastructure.

Production capacityThe supplier has 122 employees, inventory capability, documented finished-product inspection instructions, written supplier-capability assessment procedures, and one-month lead times in both peak and off seasons. However, it has no valid manufacturing-capacity contract with related subcontractors, creating a documented limitation in subcontracted capacity governance.

Customization capabilityThe supplier explicitly supports customization from samples, customization from designs, full customization, minor customization, and flexible customization. It also provides 3D software design services and ODM services, providing strong direct evidence of broad customization capability.

Product Q&A

Q:What is the purpose of a wrist splint?

A wrist splint protects the wrist, allows it to heal during intense use, holds the joint in place, and provides heat and pressure to the bones and ligaments.

Q:Are wrist splints helpful for carpal tunnel?

Yes, they keep the wrist in a straight, neutral position, relieving pressure on the median nerve. Studies show night use provides significant symptom relief.

Q:Should I wear a wrist splint at night?

Many people with mild to moderate carpal tunnel syndrome wear a splint at night for several weeks to keep the joint neutral and relieve pain.

Q:What are the indications for using this splint?

It is indicated for stable wrist fractures or dislocations, wrist sprains, carpal tunnel syndrome, wrist osteoarthritis, and external fixation after cast removal.

Q:Is customization available for this product?

Yes, we offer OEM and ODM services. Customization includes logo, materials (Aluminum Strip, Hook-Loop), colors, and packaging with a low MOQ.