Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017869684

FEI Number

3017869684

Entity Name

FULLERTON MANUFACTURING LIMITED

City/State/Country

Da Nang Bac Lieu, VN

Establishment Address

6B Street, Hoa Khanh Industrial Zone, Hoa Khanh Bac Ward,Lien Chieu District, Da Nang City, Da Nang Bac Lieu 550000, VN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fullerton Manufacturing Limited (Owner Number: 10093498)

Owner / Operator Contact Address

6B Street, Hoa Khanh Industrial Zone, Hoa Khanh Bac Ward,Lien Chieu District, Da Nang City, Da Nang, VN-55 550000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bariatric Disposable Repositioning Sling Disposable Repositioning Sling High Back Lifting Sling Slip Tube Pink Mattress

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2025-05-26
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2025-05-26
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2025-05-26

Official Correspondent

Hu Hellen

US Agent Details

Kyle Davis Email: kyle.davis@moduslight.com Phone: (913) 2837753

Related Public Records

Same Entity

Fullerton Manufacturing 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-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

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3008406502	Tollos	Sioux Falls, SD, US
3004648937	Winncare Nordic ApS	KORSOR Sjalland, DK
3013528441	Green Source Technology (Hebei) Inc.	Langfang City Hebei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017869684. Last updated year: 2026. Please use registration number 3017869684 when referencing this establishment in official correspondence.