Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027643666

FEI Number

3027643666

Entity Name

HEALTH SOURCE MEDICAL EQUIPMENT (GUANGDONG) LTD.

City/State/Country

Foshan Guangdong, CN

Establishment Address

1st floor, No. 10 West Industrial Avenue, Haimai Industrial Zone, Gaohai Community, Danzao Town, Nanhai District, Foshan Guangdong 528223, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

health source medical equipment (guangdong) ltd. (Owner Number: 10088407)

Owner / Operator Contact Address

1st floor, No. 10 West Industrial Avenue, Haimai Industrial Zone, Gaohai Community, Danzao Town, Nanhai District, Foshan, CN-GD 528223, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WALKER, MECHANICAL CHAIR AND TABLE, MEDICAL Massager, therapeutic, electric CANE Stand Assist Pack, hot or cold, water circulating Mobility Chair COMPONENT, WHEELCHAIR BED, MANUAL STAND, INFUSION

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2023-07-17
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2023-07-17
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2023-07-17
IPS	Cane	Physical Medicine	Class 1	890.3075	2023-07-17
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2024-01-23
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2023-07-17
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2025-07-16
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2025-07-16
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2023-07-17
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2025-07-16

Official Correspondent

Tingting Zhang

US Agent Details

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

Related Public Records

Same Entity

health source medical equipment (guangdong) 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-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
Z-0011-2015	Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056	1	Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.
Z-0031-2013	Winco Mfg., LLC	1	Caremor Cliner"*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 536 Serial No. 536A-101475" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Z-0032-2013	Winco Mfg., LLC	1	Caremor Cliner is labeled in part: "*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 535 Serial No. 535A-104522" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027643666. Last updated year: 2026. Please use registration number 3027643666 when referencing this establishment in official correspondence.