Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005597706

FEI Number

3005597706

Entity Name

SHENZHEN CITY U-LUCKY SPORTING GOODS CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Building 2, Lifeng Industrial Zone, Xia Cun, Gongming Town, Baoan District, Shenzhen Guangdong 518106, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shenzhen City U-Lucky Sporting Goods Co., Ltd. (Owner Number: 10027287)

Owner / Operator Contact Address

1F B Zone-2F-3F-4F Building 1, Xitian Road No# 352, Xitian Community, Gongming Town, Guangming District, Shenzhen City, CN-GD 518106, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OAM Rigid Lumbar Miami Lumbar Posteo Elbow Guard Comfort Cool KNEE JOINT AND EXTERNAL BRACE OR kit Abdominal binder Universal Elastic Rib Belt Immobilizer, Premium Shoulder Immobilizer, Sling and Swathe Formfit Shoulder Shoulder Abduction Sling Bergschultz Universal Arm Sling, Buckle Closure Arm Sling, High Arm Sling Premium Padded Arm Sling,Padded Strap Shoulder Pediatric Universal Arm Sling Premium Contact Closure Arm Sling Orthosis Limb Brace Chilling Unit Wheelchair Belt MEDICHOICE Poly/cotton drainage bag and holder Formfit Tracker Rebound Foot-Up Rebound Knee Neoprene Knee Sleeve Foot-Up Formfit ROM Knee Rebound Knee Immobilizer Universal Neoprene Wraparound Hinged Knee Support Neoprene Hinged Knee Support Exoform Knee Immobilizer Neoprene Knee Support with Stabilized Patella Exoform Dorsal Night Splint Formfit Ankle with Speedlace Spiffys Modesty Shorts External Joint & Ankle Brace Foot-Up Rebound Foot-Up Formfit Ankle with Speedlace Exoform Dorsal Night Splint MEDICHOICE Gait Belt Comfort Cool Hand Splint and Components Norco finger extension tube Formfit Thumb Formfit Universal Wrist Formfit Thumb OA Day Spectra Wrist Brace Formfit Universal Thumb Formfit Wrist Universal Thumb Splint Figure 8 Clavicle Splint and Front Closure Clavicle Support

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2022-10-30
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2016-05-13
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2014-02-18
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2013-07-18
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2008-10-21
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2008-10-21
IMF	Unit, Chilling	Physical Medicine	Class 1	890.5940	2012-07-31
IQB	Belt, Wheelchair	Physical Medicine	Class 1	890.3920	2009-11-13
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2013-01-04
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2015-12-04
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2015-12-04
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2009-09-09
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2017-02-06
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2012-08-14
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2014-04-17
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2019-10-24

Official Correspondent

Connie Chen

US Agent Details

Sarah Hassan Business: Retired Email: ssfmhassan@yahoo.com Phone: (860) 3715604

Related Public Records

Same Entity

Shenzhen City U-Lucky Sporting Goods Co., Ltd.

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

View Entity Profile →

Similar Registrations

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3017619379	Jiangsu Juneng Sports Goods Technology Co., Ltd	Yangzhou Jiangsu, CN
3013195449	DONGGUAN VINCENT REHAB DEVICES COMPANY LIMITED	DONGGUAN Guangdong, CN
3010033845	OVERLAND INT'L CORPORATION	New Taipei City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005597706. Last updated year: 2026. Please use registration number 3005597706 when referencing this establishment in official correspondence.