Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042254805

FEI Number

3042254805

Entity Name

Wealthy Plastic & Electronic Products Company Limited

City/State/Country

Huizhou City Guangdong, CN

Establishment Address

No.1, Dongjiao Village, Hantang, Guwu, Danshui, Huiyang District, Huizhou City Guangdong 516211, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Root Land Limited (Owner Number: 10094085)

Owner / Operator Contact Address

Unit F, 26/F., Montery Plaza, No. 15 Chong Yip Street, Kwun Tong, Hong Kong, HK-NOTA 999077, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Universal Cervical Collar NecLoc Miami JTO Miami Jr Miami J Select Miami J Patriot NecLoc kids Philadelphia Tracheotomy Collar Philadelphia Adjustable Collar Rebound Post Op Elbow Cold Rush Exoform Carpal Tunnel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2025-11-15
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2025-11-15
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2025-11-04
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2025-11-15

Official Correspondent

Kei Choi Tung

US Agent Details

Katla Axelsdottir Email: kaxelsdottir@ossur.com Phone: (949) 3823833

Related Public Records

Same Entity

Root Land Limited

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

Similar Registrations

Registration Number	Establishment Name	Location
3031583032	NINGBO LANDING TECHNOLOGY COMPANY CO., LTD.	Ningbo Zhejiang, CN
2242467	HAUSMANN ENTERPRISES, LLC	NORTHVALE, NJ, US
3008261717	XIAMEN COMPOWER MEDICAL TECH. CO., LTD.	Xiamen Fujian, CN
3010260768	VTS ONE MEMBER CO., Ltd.	Hai Phong City, VN
3011556461	COMFORT PLUS CORPORATION	New Taipei City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042254805. Last updated year: 2026. Please use registration number 3042254805 when referencing this establishment in official correspondence.