Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016630774

FEI Number

3016630774

Entity Name

JIANGXI AICARE MEDICAL TECHNOLOGY CO., LTD

City/State/Country

Fuzhou Jiangxi, CN

Establishment Address

No.6, South Side of Nanhuan Road Qianping Industrial Park, Le'an County, Fuzhou Jiangxi 344300, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Jiangxi AICARE Medical Technology Co., Ltd (Owner Number: 10065465)

Owner / Operator Contact Address

No.6, South Side of Nanhuan Road Qianping Industrial Park,, Le'an County, Fuzhou, CN-JX 344300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sunglasses fingertip pulse oximeter W011; fingertip pulse oximeter W013 Face mask Oral irrigatorWT101,WT102,WT103,WT105,WT106,WT107,WT108 hearing aid Infrared Forehead Thermometers A66, A68, A69 Electronic Sphygmomanometers ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24 Face mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2020-05-15
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2022-12-07
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-29
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2024-04-16
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2023-05-05
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2025-07-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-07-21
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-17

Official Correspondent

Lizhu Xiao

US Agent Details

Jessie Yao Email: info@medright-tech.com Phone: (718) 2169957

Related Public Records

Same Entity

Jiangxi AICARE Medical 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
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08
K852902	Yours Enterprise Co., Ltd.	METALLIC SUNGLASSES	1985-08-12
K970895	Custom Optical Frames, Inc.	CUSTOM OPTICAL SUNGLASS FRAMES	1997-05-06
K853921	Winsburn Company , Ltd.	ALL KINDS OF SUNGLASSES	1985-10-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

Similar Registrations

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3008137594	CHLOE SAS	PARIS Ile-de-France, FR
3042870833	GOLEADER(VIETNAM) RECREATION LIMITED	Tan Phuoc 3 Commune Dong Thap, VN
3009141079	STAGE	Sandy, UT, US
3013857947	FARFETCH ITALIA S.R.L.	MILAN Milano, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016630774. Last updated year: 2026. Please use registration number 3016630774 when referencing this establishment in official correspondence.