Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008381107

FEI Number

3008381107

Entity Name

XIAMEN J-BRACE MEDICAL EQUIPMENT CO., LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

2F,179# Tongan Park, Tongan Industrial Concnetration Area, Xiamen Fujian 361009, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xiamen J-Brace Medical Equipment Co., Ltd. (Owner Number: 10032276)

Owner / Operator Contact Address

2F79# Tongan Park, Tongan Industrial Concnetration Area, Xiamen, CN-NOTA 361009, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Shoulder Braces Supports surgical masks, respirators J-Brace, Various Shoulder Braces, K ANKLE MOTION MANAMED LENJOY MEDICAL ENGINEERING, INC MANAMED Dorsal Night Splint J-Brace and various neck braces Hernia support MANAMED Lumbar Support Finger Brace, Finger Splint Hand Brace Foot Drop Orthosis elbow and arm braces supports

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	2018-03-20
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-25
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2010-04-28
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2020-03-13
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2023-11-17
IPR	Crutch	Physical Medicine	Class 1	890.3150	2023-11-17
KMO	Binder, Elastic	General Hospital	Class 1	880.5160	2023-11-17
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2023-11-17
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2024-08-02
IQM	Splint, Temporary Training	Physical Medicine	Class 1	890.3025	2014-01-13
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2010-04-28
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2020-10-07
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2023-11-17
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2018-03-20
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2010-04-28
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2018-03-20
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2018-03-20

Official Correspondent

Li Zemei

US Agent Details

John Samorajczyk Business: Samorajczyk Regulatory Consultants, LLC Email: jsamo@prodigy.net Phone: (727) 4803810

Related Public Records

Same Entity

Xiamen J-Brace Medical Equipment Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

Similar Registrations

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3005088750	3M POLAND MANUFACTURING SP. Z O.O	WROCLAW Dolnoslaskie, PL
3013001618	CAST21 INC.	Evanston, IL, US
2184046	OSBORN MEDICAL CORPORATION	CENTENNIAL, CO, US
3006979871	TRULIFE, LTD.	S. Yorkshire Sheffield, GB
3006137579	ALIGNMED INC.	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008381107. Last updated year: 2026. Please use registration number 3008381107 when referencing this establishment in official correspondence.