Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014777423

FEI Number

3014777423

Entity Name

QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD

City/State/Country

Qingdao Shandong, CN

Establishment Address

Room 301-302, No.15 Hancheng Road, Qingdao Free Trade Zone, Shandong, China, 266555, 24th & 27th Factory Buildings, No. 252 Yanhe Road, Huangdao, Qingdao, Shandong, China, 266510, Qingdao Shandong 266555, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Qingdao Kingon Medical Science and Technology Co.,Ltd (Owner Number: 10061814)

Owner / Operator Contact Address

Room301-302, No.15 Hancheng Road, Qingdao Free Trade Zone, Shandong, China, 266555, Qingdao, CN-SD 266555, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242718

PMA Number

N/A

All Registered Proprietary Names

Portable Oxygen Concentrator, Model: POC2000 Portable Oxygen Concentrator, Model:P2-E7 Portable Oxygen Concentrator, Model:P2-E4 Portable Oxygen Concentrator, Model:P2-E Portable Oxygen Concentrator, Model:VITA-OX HD7 Portable Oxygen Concentrator, Model:P2-E6 Arya Airtivo MAX, Model: ATVMAX Portable oxygen concentrator Model:P2 Portable Oxygen Concentrator, Model:P2-TOC Portable Oxygen Concentrator, Model:TOC3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2023-06-25
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2022-06-06
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2020-04-24
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2025-03-06

Official Correspondent

Wu Xiao

US Agent Details

RHYTHM HEALTHCARE LLC RHYTHM HEALTHCARE LLC Business: RHYTHM HEALTHCARE LLC Email: yuntiana1@outlook.com Phone: (877) 8436664

Related Public Records

Same Entity

Qingdao Kingon Medical Science and Technology 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.

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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 3014777423. Last updated year: 2026. Please use registration number 3014777423 when referencing this establishment in official correspondence.