Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010101089

FEI Number

3010101089

Entity Name

WUYI COMON MEDICAL APPLIANCES CO., LTD.

City/State/Country

Jinhua City Zhejiang, CN

Establishment Address

Juhua Road, Baihuashan Industry Zone, Wuyi County, Jinhua City Zhejiang 321200, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Eclipse LLC (Owner Number: 10043660)

Owner / Operator Contact Address

123 NE 1st Ave, Delray Beach, FL 33444, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cervical Collar BIG HOOK DRESSING STICK; BUTTON HOOK; BUTTON HOOK, PLASTIC HANDLE; BUTTON HOOK/ZIPPER PULL; BUTTON H

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2018-12-18
IPR	Crutch	Physical Medicine	Class 1	890.3150	2013-03-12
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2013-03-08
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2021-03-19
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2013-03-12
IPS	Cane	Physical Medicine	Class 1	890.3075	2013-03-12
ILD	Adaptor, Dressing	Physical Medicine	Class 1	890.5050	2024-01-09
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2013-03-08

Official Correspondent

Zoltan Gyorffy

US Agent Details

Zoltan Gyorffy Business: Eclipse LLC Email: info@valentine-dynalife.com Phone: (561) 2798734

Related Public Records

Same Entity

Eclipse LLC

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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

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
9615246	TOLLOS MANUFACTURING	Barrie Ontario, CA
3009512503	MEDSOURCE FACTORY,INC.	CHANGZHOU Jiangsu, CN
3010363540	JIANGYIN CITY RUIRUN CLOTHING CO., LTD.	Jiangyin City Jiangsu, CN
3038279528	3H MEDICAL (THAILAND) CO., LTD.	Nong Yai District Chon Buri, TH
1054786	E.M. ADAMS CO., INC.	FORT PIERCE, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010101089. Last updated year: 2026. Please use registration number 3010101089 when referencing this establishment in official correspondence.