What certifications does the product have?

The product is certified by CE and FDA.

Who is the manufacturer?

Hebei Denovo Medical Device Company, a factory with over 13 years of experience.

Post-Op Foot Ankle Cast Support Splint with Air Pump

Name: Post-Op Foot Ankle Cast Support Splint with Air Pump
Brand: Hebei Denovo Medical Device Co., Ltd.
SKU: 757979092

Hebei, ChinaHebei Denovo Medical Device Co., Ltd.

US$6.00-9.00

1,000 Pieces

Sample price:US$15.00/piece.Request sample

Product profile

Customization

Available

Customized

Certification

ISO, CE

Model NO.

DNHH-04A

Condition

New

Usage

Fracture Fixation

Using Site

Foot Ankle

Type

Splint Fixation

Material

Medical PE, Gel, Suede Belt

Size

Universal Size

Colors

Black, White

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

Inflatable Ankle Support: Semi-rigid shells lined with inflatable air stabilize and protect the ankle joint.

Stirrup Design: Provides pulsating compression to reduce swelling and edema while walking.

Versatile Usage: Ideal for severe sprains, fractures, post-op rehabilitation, and chronic instability.

Sports Prevention: Perfect for basketball, soccer, volleyball, and athletics involving jumping and running.

Customized Logo: Logo customization is accepted for branding purposes.

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

OEM and ODM Service: Professional manufacturer offering OEM and ODM services for trading companies.

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

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: ≤2.72hTerms 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.