Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003775119

FEI Number

3003775119

Entity Name

GENTRY HARDWARE PRODUCTS CO. LTD.

City/State/Country

Zhong Shan City Guangdong, CN

Establishment Address

No.158, Dong Cheng Road, Xiaolan Town, Zhong Shan City Guangdong 528414, CN

Establishment Type(s)

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

Owner / Operator

GENTRY HARDWARE PRODUCTS CO. LTD. (Owner Number: 9049686)

Owner / Operator Contact Address

No.158, Dong Cheng Road, Xiaolan Town, Zhong Shan City, CN-GD 528414, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

QUADCANES LUMEX Lift, Patient, Non-AC Powered Gentry Oxygen Carts Nonmeasuring Exercise Equipment LUMEX COMMODE TRANSFER BENCH TIP CANE CRUTCH WALKERS Right Medical Supplies LUMEX Sterling Medical LUMEX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2006-10-03
IPR	Crutch	Physical Medicine	Class 1	890.3150	2002-02-08
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2024-04-17
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2012-05-30
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2025-08-14
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2002-05-30
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2006-10-03
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2006-08-16
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2002-02-08
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2002-05-30

Official Correspondent

ECHO WANG

US Agent Details

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

Related Public Records

Same Entity

GENTRY HARDWARE PRODUCTS CO. LTD.

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-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

Similar Registrations

Registration Number	Establishment Name	Location
3014066423	SHOP LC Global Inc.	Austin, TX, US
3031606416	ORTHOTECH REHABILITATION CO., LTD.	Xiamen Fujian, CN
3013823570	GUANGZHOU BAOLI HARDWARE & ELECTRONIC CO.,LTD.	Guangzhou Guangdong, CN
3035374295	ONLYCARE INC	Denver, CO, US
3010987649	DYNAFOCUS INDUSTRY CO., LTD.	New Taipei City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003775119. Last updated year: 2026. Please use registration number 3003775119 when referencing this establishment in official correspondence.