Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033859527

FEI Number

3033859527

Entity Name

FOSHAN KYCARE MEDICAL EQUIPMENT CO. LTD

City/State/Country

Foshan City Guangdong, CN

Establishment Address

Room 401, Building 29, Liandong Yougu Park, No. 3 Dongsan District, Jiansha Road, Danzao Town, Nanhai District, Foshan City Guangdong 528000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Foshan KYCARE Medical Equipment Co. Ltd (Owner Number: 10091799)

Owner / Operator Contact Address

Room 401, Building 29, Liandong Yougu Park, No. 3 Dongsan District, Jiansha Road, Danzao Town, Nanhai District, Foshan City, CN-GD 528000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Oxygen Concentrator (J5A) ZY5BA Oxygen Concentrator Oxygen Concentrator (Model: J10A) KYCARE J10A OXYGEN CONCENTRATOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2025-11-25
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2025-05-30
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2026-01-07
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2025-05-30

Official Correspondent

Leona Zhou

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

Foshan KYCARE Medical Equipment 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
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27
K042262	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10	2004-09-10
K003472	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM	2001-06-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.

Similar Registrations

Registration Number	Establishment Name	Location
3004964590	AVOX SYSTEMS	Lancaster, NY, US
3008841036	Oxus America, Inc.	Orion Township, MI, US
3016809216	GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD.	Guangzhou City Guangdong, CN
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ
3013095415	VENTEC LIFE SYSTEMS, INC.	Bothell, WA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033859527. Last updated year: 2026. Please use registration number 3033859527 when referencing this establishment in official correspondence.