Evolve Medical Evolve Medical

Orthopedic Breathable Airfoam Anklle Brace with CE and FDA

Customization: Available
Customized: ODM&OEM
Certification: ISO, CE, FDA

Product Description

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Basic Specifications

Model NO.
AS009-B
Condition
New
Usage
Fracture Fixation
Using Site
Ankle
Type
External Fixator
Logo
As Your Request
Lead Time
45 Days
Materials
Medical PE; Foam; Suede Belt
Package
1 Polybag/PC or Customized Box
HS Code
9021100090
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Product Overview

Medical Indications:
  • Ankle sprains and ankle ligament strains
  • External fixation after cast removal
  • Chronic instability of the ankle joint (habitual broken foot)
  • Peroneal ligament injury (grade II to grade III)
Key Features:
  • Outer plastic plate design provides stable ankle joint support
  • Strap design for a better fit and compression
  • Solid rivets combine straps with plastic plate for maximum durability
  • Inflatable device adjusts to ankle shape and reduces swelling with pressure
  • Built-in sponge lining ensures comfort during extended wear
  • Adjustable heel width suitable for various body types

Available Sizes: S / M / L

Ankle Brace View 1
Ankle Brace View 2
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Manufacturing & Quality Control

As a professional manufacturer specializing in orthopedic rehabilitation products, we focus on the research, development, and production of high-quality braces. Our facility is certified with ISO13485 quality management systems, ensuring every product meets rigorous medical standards.

We provide comprehensive OEM and ODM services with low MOQ requirements. Our customization capabilities include design, logo application, material selection (Neoprene, SBR, Nylon, OK cloth), and specialized sizing for children and teenagers. All products comply with CE and FDA standards, serving markets across Europe and the United States.

Production Facility
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Certifications & Process

Quality Certifications
Production Process

Why Choose Our Solutions

  • Competitive Manufacturer Pricing: Direct supply from the source to ensure cost-effectiveness.
  • Industry Qualified: Full compliance with ISO13485, CE, FDA, and MDR standards.
  • Advanced Technology: Utilization of high-quality raw materials and strict quality control procedures.
  • Professional Team: Dedicated experts providing professional OEM/ODM and customer services.
  • Volume Advantages: Better pricing tiers available for large quantity orders.
Factory Outlook
Global Customers
Exhibition Presence

Frequently Asked Questions

What conditions is this ankle brace designed for?
It is specifically designed for ankle sprains, ligament strains, post-cast fixation, chronic instability, and peroneal ligament injuries (Grade II to III).
What makes the support stable?
The brace features an outer plastic plate design and solid rivet construction combined with an inflatable device that conforms to your ankle's unique shape.
Is the size adjustable for different users?
Yes, the brace comes in S/M/L sizes and features an adjustable heel width to ensure a perfect fit for any body type.
Are the materials safe for skin contact?
We use high-quality medical PE, foam, and comfortable suede belts. The built-in sponge ensures the device is comfortable even during long-term use.
Do your products meet international medical standards?
Absolutely. All our orthopedic products are industry-qualified and comply with ISO13485, CE, FDA, and MDR standards.
Can I request a customized logo or design?
Yes, we offer full OEM and ODM services, including customized logos, materials, colors, and specialized packaging at low MOQs.

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