What certifications does the product hold?

The product is certified by CE, FDA, and ISO13485.

How is the product packaged?

It comes in a neutral OPP bag, with 50 pieces per carton (Carton size: 50*40*40cm).

What is the lead time for orders?

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

Adjustable Foot Dorsal Night Splint Support for Plantar Fasciitis Pain

Name: Adjustable Foot Dorsal Night Splint Support for Plantar Fasciitis Pain
Brand: Hebei Denovo Medical Device Co., Ltd.
SKU: 753261112

Hebei, ChinaHebei Denovo Medical Device Co., Ltd.

US$3.50-4.50

50 Pieces

Sample price:US$10.00/piece.Request sample

Product profile

Customization

Available

Type

Orthopedics

Function

Pain Relief

Model NO.

DNOR-AF02-4

Theory

Physical

Certification

CE, FDA, ISO13485

Group

Adult

Packaging Size

30X20cm Zipper Bag

Packaging Spec

50PCS/Carton of 50*40*40cm

Shelf Life

Five Years

Service

OEM

Transport Package

OPP Bag

Specification

92G

Trademark

DR. YAN

Origin

Hebei

HS Code

6307900000

Production Capacity

2000 PCS/Month

Key features

90-Degree Dorsiflexion Support: Bendable aluminum bar positions foot at 90 degrees to stretch fascia and relieve pain.

Ultra Soft Foam Padding: Fully padded lining with soft foam insert reduces pressure points for comfortable sleep.

Adjustable Tension Straps: Straps allow angle adjustment from 90 to 85 degrees for a custom comfortable fit.

Breathable Open Heel Design: Low profile design with open heel ensures cool and breathable foot comfort during sleep.

Universal Fit for All Sizes: Free size design is universal for both left and right feet of unisex adults.

CE, FDA, ISO13485 Certified: Product meets international safety and quality standards for medical devices.

Customizable Logo and Colors: Logo customization accepted and other colors available beyond standard black.

OEM Service Available: Factory offers OEM and ODM services with competitive pricing and premium quality.

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: ≤1.26hTerms 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.