What certifications does the product have?

The product holds CE, FDA, and ISO13485 certifications.

How is the product packaged?

It comes in a neutral OPP bag, with 50 pieces per carton.

Amazon Plantar Fasciitis Night Splint for Pain Relief Sleep Support

Name: Amazon Plantar Fasciitis Night Splint for Pain Relief Sleep Support
Brand: Hebei Denovo Medical Device Co., Ltd.
SKU: 753629192

Hebei, ChinaHebei Denovo Medical Device Co., Ltd.

US$3.50-4.50

100 Pieces

Sample price:US$10.00/piece.Request sample

Product profile

Customization

Available

Type

Orthopedics

Function

Pain Relief

Model NO.

DNOR-AF02-1

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

210G

Trademark

DR. YAN

Origin

Hebei

HS Code

6307900000

Production Capacity

2000 PCS/Month

Key features

Customizable Color Options: Available in Black with other colors customizable upon request.

Adjustable Dorsiflexion Angle: Tension straps allow adjustment of foot angle from 90 to 85 degrees.

Ultra-Soft Foam Padding: Features soft foam lining to reduce pressure points for comfortable sleep.

OEM and ODM Services: Professional manufacturer offering custom logo and packaging services.

Universal Fit Design: Free size suitable for both left and right feet of unisex adults.

Breathable Open Heel: Low profile design with open heel for cool and breathable comfort.

Certified Quality: Products certified by CE, FDA, and ISO13485 standards.

Flexible MOQ Policy: Small orders accepted due to sufficient inventory availability.

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.