Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029702497

FEI Number

3029702497

Entity Name

XIAMEN TWE ORTHOPEDICS CO., LTD

City/State/Country

Xiamen Fujian, CN

Establishment Address

5th Floor, Building 4, No.29 Xinle Road, Haicang District, Xiamen Fujian 361000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

XIAMEN TWE ORTHOPEDICS CO., LTD (Owner Number: 10088838)

Owner / Operator Contact Address

5th Floor, Building 4, No.29 Xinle Road, Haicang District, Xiamen, CN-FJ 361000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ELBOW BRACE HIP BRACE SHOULDER IMMOBILIZER ARM SLING WRIST BRACE CERVICAL COLLAR ANKLE BRACE KNEE BRACE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2023-10-16
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2023-10-16
ILE	Sling, Arm, Overhead Supported	Physical Medicine	Class 1	890.3475	2023-10-16
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2023-10-16
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2023-10-16
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2023-10-16
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2023-10-16
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2023-10-16

Official Correspondent

Huazheng Qiu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

XIAMEN TWE ORTHOPEDICS 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 3029702497. Last updated year: 2026. Please use registration number 3029702497 when referencing this establishment in official correspondence.