What certifications does the product hold?

The product holds ISO13485, CE, FDA, and MDR certifications.

What are the available sizes?

The brace is available in sizes S, M, L, XL, and 2XL.

Breathable Mesh Back Brace with CE and FDA

Name: Breathable Mesh Back Brace with CE and FDA
Brand: Xiamen Huakang Orthopedic Co., Ltd.
SKU: 2017750185

Fujian, ChinaXiamen Huakang Orthopedic Co., Ltd.

US$7.15-12.87

300 Pieces

Product profile

Customization

Available

Customized

ODM&OEM

Certification

ISO, CE, FDA

Model NO.

BS010-A

Condition

New

Usage

Fracture Fixation

Using Site

Waist

Type

External Fixator

Logo

as Your Request

Lead Time

45 Days

Materials

Mesh Fabric; Aluminum Strip

Transport Package

1 Polybag/PC or Customized Box

Trademark

Huakang Ortho

Origin

Xiamen, China

HS Code

9021100090

Key features

Breathable Mesh Design: Constructed with mesh fabric for excellent air circulation and comfort.

Strong Aluminum Support: Built-in aluminum bar provides firm support for waist injuries.

Easy Velcro Adjustment: Features a velcro design for quick and easy application and removal.

Extended Coverage Area: Widening and heightening design increases the support surface area.

Multiple Size Options: Available in S, M, L, XL, and 2XL to fit various body types.

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

ISO13485 Quality System: Manufactured under strict ISO13485 quality management certification.

Full Customization Available: Supports OEM/ODM with custom logo, material, color, and packaging.

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: ≤8.83h

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.