Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021282525

FEI Number

3021282525

Entity Name

XIAMEN BOSEGROW MEDICAL EQUIPMENT CO.,LTD

City/State/Country

Xiamen Fujian, CN

Establishment Address

401, NO.69-2, Zhaihoubei Road, Haicang District, Xiamen 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 Bosegrow Medical Equipment Co.,Ltd (Owner Number: 10083382)

Owner / Operator Contact Address

2F-A, Building 5, NO.68, Shishan Road, Haicang District, Xiamen, CN-FJ 361027, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Walker Boot; Corrective Shoe Ankle Brace ; Ankle Foot Orthosis; Drop Foot Brace Cervical Collar Crutches Knee Brace; Knee Immobilizer; Hinged Knee Support Finger Splint; Hand Brace Night Splint; Dorsal Night Splint Hip Abduction Brace Shoulder/Arm Sling; Wrist Brace Lumbar Support ; Waist Brace Shoulder Abduction Brace; Elbow Brace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2021-11-16
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2021-11-16
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2021-11-16
IPR	Crutch	Physical Medicine	Class 1	890.3150	2021-11-16
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2021-11-16
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2021-11-16
IQM	Splint, Temporary Training	Physical Medicine	Class 1	890.3025	2021-11-16
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2021-11-16
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2021-11-16
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2021-11-16
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2021-11-16

Official Correspondent

Xunhui Gao

US Agent Details

Noah Zhang Business: HYPERCERT LIMITED Email: noah.zhang@hycerglobal.com Phone: (302) 6089028

Related Public Records

Same Entity

Xiamen Bosegrow Medical Equipment 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021282525. Last updated year: 2026. Please use registration number 3021282525 when referencing this establishment in official correspondence.