Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016809216

FEI Number

3016809216

Entity Name

GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD.

City/State/Country

Guangzhou City Guangdong, CN

Establishment Address

Room A101, No.5 Kesheng Road,Guangzhou Private Science and Technology Park,No.1633 Beitai Road,, Baiyun District, Guangzhou City Guangdong 510540, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangzhou Life Light Electronic Technology Co., Ltd. (Owner Number: 10079265)

Owner / Operator Contact Address

Room A101, No.5 Kesheng Road,Guangzhou Private Science and Technology Park,No.1633 Beitai Road, Baiyun Distric, Guangzhou City, CN-GD 510540, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191875

PMA Number

N/A

All Registered Proprietary Names

Owgels Oxygen Concentrator , Model: OZ-5-02TW0 Oxygen Concentrator, Model: OZ-5-02TW0 Oxygen Concentrator, Model: 1400-5100,R-DOC5200

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2020-11-26

Official Correspondent

Zhanhui Su

US Agent Details

Dennis Xu Email: ybx99@yahoo.com Phone: (919) 8590478

Related Public Records

Same Entity

Guangzhou Life Light Electronic 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.

Similar Registrations

Registration Number	Establishment Name	Location
3004964590	AVOX SYSTEMS	Lancaster, NY, US
3008841036	Oxus America, Inc.	Orion Township, MI, US
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ
3013095415	VENTEC LIFE SYSTEMS, INC.	Bothell, WA, US
2515872	DeVilbiss Healthcare LLC.	SOMERSET, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016809216. Last updated year: 2026. Please use registration number 3016809216 when referencing this establishment in official correspondence.