Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005621301

FEI Number

3005621301

Entity Name

DONGGUAN NAN YOU SPORTING GOODS ENTERPRISE LTD

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Lingxia Village, Liaobu Town, Dongguan Guangdong --, CN

Establishment Type(s)

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

Owner / Operator

TIEN JIANG ENTERPRISE CO., LTD. (Owner Number: 9056877)

Owner / Operator Contact Address

3F., NO.20, LANE 619,, CHUNG HWA RD.,YUNG KANG CITY, TAINAN HSIEN, TW-NOTA 710, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Binder, Abdominal support pad cane Foot Brace Shoe brace support Wrist Support Knee Support Open Patella Knee Sleeve Knee Strap Close Patella Knee Sleeve CUP SUPPORTER SUPPORT SHORTS, JOCK STRAPS LITE SUPPORT SHORTS YOUTH ATHL CUP SUPPORTER SUPPORT brace brace, support COOLING TOWEL elastic braces ; Elastic Back Belts Orthotic, Lumbar-sacral Thigh Support Wrist Brace Ankle Support Arch Wrap Achilles Wrap Elbow Support WRIST SUPPORT COVERALLS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2021-03-28
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2011-03-27
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2016-03-16
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2022-04-01
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2011-03-27
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2021-06-18
KFT	Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical	Physical Medicine	Class 1	890.3420	2020-06-11
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2008-08-04
FQJ	Support, Scrotal, Therapeutic	General Hospital	Class 1	880.5820	2017-05-31
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2012-07-12
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2012-07-15
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2006-03-02
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2010-06-08
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2008-08-04
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2012-07-12
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2008-08-04
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2008-08-04
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-07-10

Official Correspondent

Stacy Cheng

US Agent Details

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

Related Public Records

Same Entity

TIEN JIANG ENTERPRISE CO., LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010508273	LIANG CHENG SPORTING GOODS COMPANY LIMITED	Ben Cat Town Binh Duong, VN
3003849847	TIEN JIANG ENTERPRISE CO., LTD.	TAINAN CITY, TW

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005621301. Last updated year: 2026. Please use registration number 3005621301 when referencing this establishment in official correspondence.