What certifications does the product have?

The product is certified by ISO, CE, and FDA.

What is the lead time for production?

Lead time is one month during peak season and within 15 workdays during off-season.

Does the manufacturer offer OEM services?

Yes, the manufacturer provides OEM and ODM services including custom logo options.

Ankle Brace with Detachable Splints for Sprained Ankle

Name: Ankle Brace with Detachable Splints for Sprained Ankle
Brand: Hebei Denovo Medical Device Co., Ltd.
SKU: 2017947562

Hebei, ChinaHebei Denovo Medical Device Co., Ltd.

US$2.50-2.80

100 Pieces

Sample price:US$10.00/piece.Request sample

Product profile

Customization

Available

Customized

Non-Customized

Certification

ISO, CE

Model NO.

DNOR-F03

Condition

New

Usage

Correct Deformities, Fracture Fixation

Using Site

Ankle

Type

External Fixator

Size

Free Size

Color

Black

Material

Neoprene an Aluminum Splints

Service

OEM / ODM

Transport Package

Plastic Bag and Carton

Specification

150g

Trademark

DENOVO

Origin

Hebei

HS Code

9021100090

Production Capacity

2000 PCS/Month

Key features

Detachable Aluminum Splints: Removable strips allow free adjustment of position and angle for a secure fit.

High Elastic Straps: 8-shaped straps enhance stability and distribute joint stress effectively.

Durable Construction: High-density suture ensures long-lasting performance for daily use.

Multi-Condition Relief: Reduces pain from sprains, arthritis, swelling, bursitis, and tendonitis.

CE and FDA Certified: Products meet international safety and quality standards for medical devices.

OEM and ODM Service: Custom logo and branding options available for trading companies.

Experienced Manufacturer: Over 13 years of professional experience in orthopedic brace production.

Competitive Pricing: Factory-direct pricing with assured premium quality for bulk orders.

Company profile

Hebei Denovo Medical Device Co., Ltd.

Hebei, China

Business Type: Manufacturer/Factory, Trading CompanyExport Year: 2014-04-01Nearest Port: TIANJIN, SHANGHAI, BEIJINGAverage Response Time: ≤3.07hTerms of Payment: T/T, PayPal, Western UnionInternational Commercial Terms(Incoterms): FOB, CFR, CIF, EXW

AI-Powered supplier vetting

SummaryThe supplier is a China-based manufacturer and seller of Class I medical devices and sports protective gear, with stated factory experience exceeding 10 years, one production line, and 11–20 R&D engineers and quality-control staff. It reports ISO 13485, ISO 9001, GMP, CE, and SGS-related certifications, offers OEM and broad customization services, and exports to multiple regions. Production information is inconsistent: the stated annual output exceeds US$100 million, while specific disclosed quantities are 200,000 back supports and 200,000 knee supports. Quality control is limited to finished-product checking by packing staff, and service-capability procedures and corrective-action records are not documented. The supplier has a complaint-handling procedure, but no overseas warehouse, showroom, agent or branch, or offline trade-show participation. Financial evidence is insufficient because only reporting years are provided, without financial results.

Supplier typeThe supplier identifies itself as a real factory with more than 10 years of experience and conducts production and sales of Class I medical devices and sports protective gear. Its stated manufacturing location is in Anping County, Hengshui City, Hebei Province, China, and it operates one production line.

CertificationsThe supplier states that its products are certified by CE, SGS, and ISO 13485, and separately lists ISO 13485, ISO 9001, and GMP for supplier management systems. These statements provide explicit certification evidence, although the specific certified products and certificate validity are not detailed.

R&D capabilityThe supplier reports 11–20 R&D engineers, continuous manufacturing-skill innovation, and development of its own DR YAN brand. It does not provide an SDK, so software-development capability is absent, but the available evidence supports product and manufacturing innovation capability.

Production capacityThe supplier describes itself as a real factory with more than 10 years of experience and reports one production line, annual output stated as above US$100 million, and specific quantities of 200,000 back supports and 200,000 knee supports. It also reports 11–20 quality-control staff, although finished products are checked by packing staff and the production figures are not fully consistent in format.

Customization capabilityThe supplier provides OEM services and lists customization from samples, designs, full customization, minor customization, and flexible customization. This is explicit evidence of broad customization capability.

Client casesThe supplier states that its DRYAN products are sold in orthopedic and hospital channels and that products have been exported to the United States, United Kingdom, South Africa, Greece, the Middle East, and other regions. These are claimed market and geographic cases, but no named customers or independently verifiable case details are provided.