Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008903689

FEI Number

3008903689

Entity Name

XIAMEN HUAKANG ORTHOPEDIC CO.,LTD

City/State/Country

Xiamen City Fujian, CN

Establishment Address

2F,Building #13, No. 2881 Dongfu Avenue, Haicang District, Xiamen City Fujian 361027, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Xiamen Huakang Orthopedic Co.,Ltd (Owner Number: 10055922)

Owner / Operator Contact Address

2F,Building #13, No. 2881 Dongfu Avenue, Haicang District, Xiamen City, CN-FJ 361027, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Limb brace Ankle, external brace Cervical collar Isolation Gown Lumbo-Sacral back brace Shoulder/Arm Sling Face Mask Scoliosis Brace elbow brace, hand braces, hip brace, foot brace knee brace, Hand Splint Positioning Straps Abdominal Binder crutches Clavicle Splint Goggles

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2017-10-18
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2017-10-18
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2017-10-18
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-29
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2017-10-18
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2017-10-18
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-13
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2025-01-08
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2018-11-12
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2017-10-18
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2022-08-19
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2017-10-18
IPR	Crutch	Physical Medicine	Class 1	890.3150	2018-11-12
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2017-10-18
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-03-29

Official Correspondent

Yong Xiao

US Agent Details

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

Related Public Records

Same Entity

Xiamen Huakang Orthopedic Co.,Ltd

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

View Entity Profile →

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

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3012951155	Zhejiang Steriger Sports Medicine Technology Co.,Ltd	Yiwu Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008903689. Last updated year: 2026. Please use registration number 3008903689 when referencing this establishment in official correspondence.