Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014204631

FEI Number

3014204631

Entity Name

DONGGUAN WELL SPORT CO LTD

City/State/Country

Dongguan Guangdong, CN

Establishment Address

NO 179-2 HONGLI RD LIAOBU TOWN, Dongguan Guangdong 523000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

DONGGUAN WELL SPORT CO LTD (Owner Number: 10056643)

Owner / Operator Contact Address

NO 179-2 HONGLI RD LIAOBU TOWN, Dongguan, CN-GD 523000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ankle Brace Wrist Brace Knee Brace Catheter Arm Sling Back Brace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2017-12-28
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2017-12-29
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2017-12-28
OAG	Garment, Storage, Peritoneal Dialysis Catheter	Physical Medicine	Class 1	890.5050	2019-02-26
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2017-12-29
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2017-12-29
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2026-03-20

Official Correspondent

QingYing Lei

US Agent Details

Andy Opliger Email: andyo@united-ortho.com Phone: (260) 4456202

Related Public Records

Same Entity

DONGGUAN WELL SPORT CO LTD

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3020880065	TAYCO BRACE, INC	South Bend, IN, US
3027285106	BETTERGUARDS TECHNOLOGY GMBH	Hennigsdorf Brandenburg, DE
3043364423	SAMGEN MEDICAL LLC	Cherry Hill, NJ, US
3010646683	HARNOSANDS PLASTINDUSTRI AB	Harnosand Vasternorrland, SE
3012164853	Wilsons nc Enterprice LLC	Washington, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014204631. Last updated year: 2026. Please use registration number 3014204631 when referencing this establishment in official correspondence.