Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014060494

FEI Number

3014060494

Entity Name

XIAMEN DELAND MEDICAL EQUIPMENT CO., LTD.

City/State/Country

XIAMEN Fujian, CN

Establishment Address

NO. 358, JIQUN RD., TONGAN DISTRICT,, XIAMEN Fujian 361100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xiamen Deland Medical Equipment Co., Ltd. (Owner Number: 10056011)

Owner / Operator Contact Address

NO. 358, JIQUN RD., TONGAN DISTRICT,, XIAMEN, CN-FJ 361100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Joint Ankle, External Brace - Ankle supports and braces series Walker braces series, Silicone foot care products series Orthosis, Thoracic - Rib belts series, Spine support series Joint, knee, External brace - Knee braces with splint Splint, Clavicle - Clavicle supports and Maternity support belt Splint, Hand, and components - Finger Splints series Wrist supports with Splints series, Elbow support Series Orthosis, Cervical - Cervical collars series Orthosis, Hot or Cold supports - Arm, elbow, Lumber, knee, ankle hot or cold supports Orthosis Lim brace - Shin support, Elbow, and calf support

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2017-10-27
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2017-10-27
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2017-10-27
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2017-10-27
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2017-10-27
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2017-10-27
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2017-10-27

Official Correspondent

Yaozong Wang

US Agent Details

Wilson Li Business: REPF America LLC Email: qagujdsvvt@outlook.com Phone: (719) 2013315

Related Public Records

Same Entity

Xiamen Deland 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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3043364423	SAMGEN MEDICAL LLC	Cherry Hill, NJ, US
3010646683	HARNOSANDS PLASTINDUSTRI AB	Harnosand Vasternorrland, SE
3012164853	Wilsons nc Enterprice LLC	Washington, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014060494. Last updated year: 2026. Please use registration number 3014060494 when referencing this establishment in official correspondence.