What certifications does the product have?

The product is certified by CE and FDA.

What is the lead time for production?

Peak season lead time is one month, and off-season is within 15 workdays.

Premium Air Gel Ankle Support for Enhanced Comfort and Stability

Name: Premium Air Gel Ankle Support for Enhanced Comfort and Stability
Brand: Hebei Denovo Medical Device Co., Ltd.
SKU: 759123512

Hebei, ChinaHebei Denovo Medical Device Co., Ltd.

US$5.00-8.00

1,000 Pieces

Sample price:US$5.00/piece.Request sample

Product profile

Customization

Available

Customized

Certification

ISO, CE

Model NO.

DNHH-04AG

Condition

New

Usage

Fracture Fixation

Using Site

Foot Ankle

Type

Splint Fixation

Material

Medical PE, Gel, Suede Belt

Size

Universal Size

Colors

Black,White

Shelf Life

Five Years

Service

OEM

Function

Ankle Stable Support

Transport Package

Neutral PE Bag and Carton

Specification

280g

Trademark

DR. YAN or customized

Origin

China

HS Code

9021100000

Production Capacity

2000 PCS/Month

Key features

Medical Grade Materials: Constructed with Medical PE, Gel, and Suede Belt for durability and comfort.

CE and FDA Certified: Products are certified by CE and FDA ensuring safety and regulatory compliance.

Customized Logo Service: Customized logo is accepted for branding and OEM requirements.

Universal Size Fit: Designed as a universal size suitable for unisex adults.

Versatile Color Options: Available in Black and White to suit different preferences.

Post-Op and Injury Support: Ideal for sprains, strains, post-op cast support, and fracture fixation.

13 Years Manufacturing Experience: Factory with over a decade of experience in orthopedic braces and splints.

Small Order Accepted: MOQ requirements are flexible, allowing for small order placements.

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: ≤1.37hTerms 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.