Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020994856

FEI Number

3020994856

Entity Name

AOJ HEALTH TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Building No.1,1-3F, Building No.2,2F, AOJ Industrial Park, Sanwei Community, Hangcheng Street, Baoan District, Shenzhen Guangdong 518126, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AOJ HEALTH Technology Co., Ltd. (Owner Number: 10084496)

Owner / Operator Contact Address

Building No.1,1-3F, Building No.2,2F, AOJ Industrial Park, Sanwei Community, Hangcheng Street, Bao'an District, Shenzhen, CN-GD 518126, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Atomizing Nasal Irrigator ANI-801, ANI-802, ANI-803, ANI-804 Nasal Aspirator ASP-401, Nasal Aspirator ASP-402 Electric Breast Pump (BRP-301, 302, 303, 304, 305, 306, 307, 308, 201, 202, 203) Otoscope OT-503 Ear Wax Removal Tool Camera EWR-10, EWR-50 Otoscope OT-501 Ultrasonic Cleaner USC-10 Ultrasonic Cleaner USC-20 Insect Bite Healer IBR 10, IBR 20, IBR 30, IBR 40, IBR 50, IBR 60 Insect Bite Healer IB 50E, IB 80, IB 100, IB 150, IB 200,IB A50, IB 550 Insect Bite Healer IBR70, IBR75, IBR80, BR100, BR200, BR70, BR75, IBR600, IBR700, IBR800, IBR900

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2025-07-02
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2026-04-28
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2024-09-02
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2023-10-26
JER	Cleaner, Denture, Mechanical	Dental	Class 1	872.3530	2024-09-05
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2023-11-22

Official Correspondent

Jack Wang

US Agent Details

Clare Ho Email: cfrhealthcare@foxmail.com Phone: (323) 6333835

Related Public Records

Same Entity

AOJ HEALTH 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
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

Similar Registrations

Registration Number	Establishment Name	Location
2032685	HEALTH SOLUTIONS MEDICAL PRODUCTS, CORP.	LOS ANGELES, CA, US
3013257234	MINGZHEN (DONGGUAN) ELECTRONICS CO., LTD	Dongguan Guangdong, CN
3015277818	HANGZHOU WEIZE IMP & EXP CO., LTD	Hangzhou Zhejiang, CN
3042277519	CHANGZHOU SAISHENG MEDICAL TECHNOLOGY CO., LTD	Changzhou Jiangsu, CN
3018975080	SHENZHEN MICRO ELECTRIC INTELLIGENCE CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020994856. Last updated year: 2026. Please use registration number 3020994856 when referencing this establishment in official correspondence.