Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017406171

FEI Number

3017406171

Entity Name

XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD

City/State/Country

Xuzhou Jiangsu, CN

Establishment Address

1st&2nd Floor,6#01,6#02,No.6 Building 1st Phase Economic Development Manufacturing Zone, LIANDO U Valley, No.6 Leye Road,Xuzhou ETDZ, Xuzhou Jiangsu 221000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xuzhou Yongkang Electronic Science Technology Co., Ltd (Owner Number: 10054941)

Owner / Operator Contact Address

1st&2nd Floor,6#01,6#02,No.6 Building 1st Phase Economic Development Manufacturing Zone, LIANDO U Valley, No.6, Leye Road ,Xuzhou ETDZ,221000 Xuzhou,PEOPLE'S REPUBLIC OF CHINA, xuzhou, CN-JS 221000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Electronic moxibustion Therapy Cupping Massager Nebulizer UV Radiation Treatment System-YK-6000A,YK-6000A-T,YK-6000B,YK-6000B-T Fingertip Pulse Oximeter,okids,YK-82A,YK-82B,YK-82C Fingertip Pulse Oximeter, Ox with Respiration Rate Monitoring, Heart Rate, PI & RR Measurements, YK-80C Fingertip Pulse Oximeter ,YK-80A,YK-80B,YK-80C,YK-81A,YK-81B,YK-81C,YK-83A,YK-83B,YK-83C,YK-84A,YK-84B,YK-84C Handheld Pulse Oximeter, Can continuously monitor, Adjustable pulse and SpO2 level alarm, Model: YK-82B Braun Pulse Oximeter :BPX801US Pulse oximeter,Handheld oxygen saturation monitor -Continuous infant monitoring; Model: YK-82A Infrared Thermometer-IRT1 IRT2 IRT3 IRT4 water flosser YK-81A,YK-81B,YK-81C,YK-82A,YK-82B,YK-82C,YK-83A,YK-83B,YK-83C-Fingertip Pulse Oximeter BPX800US-Fingertip Pulse Oximeter BPX801US-Fingertip Pulse Oximeter YK-80A,YK-80B,YK-80C,YK-84A,YK-84B,YK-84C -Fingertip Pulse Oximeter Fingertip Pulse Oximeter YK-61C1 SKIN TAG REMO electric toothbrush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2024-07-22
JPW	Pump, Nebulizer, Electrically Powered	Ear, Nose, Throat	Class 1	874.5220	2024-09-11
FTC	Light, Ultraviolet, Dermatological	General, Plastic Surgery	Class 2	878.4630	2020-02-08
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2018-11-21
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-07-15
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2023-08-21
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2017-05-16
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-10-16
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2023-08-21

Official Correspondent

Pei Yu

US Agent Details

Qihui Zhang Business: ZYPPEL LLC Email: Qzhang@Zyppel.Com Phone: (617) 2991655

Related Public Records

Same Entity

Xuzhou Yongkang Electronic Science 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
K800950	Tanit, Inc.	TANIT HOME SUNTANNING UNIT	1980-06-04
K230382	Daavlin Distributing Co.	3 Series NeoLux	2023-03-24
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017406171. Last updated year: 2026. Please use registration number 3017406171 when referencing this establishment in official correspondence.