Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004101653

FEI Number

3004101653

Entity Name

WINNING INDUSTRIAL CO., LTD.

City/State/Country

DONGGUAN Guangdong, CN

Establishment Address

Hua Nan Industrial Zone, No.10 Jin-Fu Road, LIAOBU, DONGGUAN Guangdong 523405, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device

Owner / Operator

WINNING INDUSTRIAL CO., LTD. (Owner Number: 9057615)

Owner / Operator Contact Address

Hua Nan Industrial Zone, No.10 Jin-Fu Road, Dong Guan, CN-GD 523405, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2011-03-02
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2015-10-15
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2015-10-15
FQJ	Support, Scrotal, Therapeutic	General Hospital	Class 1	880.5820	2013-11-19
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2011-03-02
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2023-03-13
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2012-03-09

Official Correspondent

Ally Lai

US Agent Details

Wendy Ko Business: Glomex, Inc. Email: wko@glomexusa.com Phone: (909) 9470288

Related Public Records

Same Entity

WINNING INDUSTRIAL CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004101653. Last updated year: 2026. Please use registration number 3004101653 when referencing this establishment in official correspondence.