Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005621440

FEI Number

3005621440

Entity Name

FAMIDOC TECHNOLOGY CO., LTD

City/State/Country

Dong Guan Guangdong, CN

Establishment Address

Building 6, Zhongtangtian'An Cyber Park, No. 89, Jinyuan Road, Zhongtang Town, Dong Guan Guangdong 523220, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FAMIDOC TECHNOLOGY CO., LTD. (Owner Number: 9078379)

Owner / Operator Contact Address

Building 6, Zhongtang Tian'an Cyber Park, No. 89, Jinyuan Road, Zhongtang Town, Dongguan, CN-GD 523220, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191673

PMA Number

N/A

All Registered Proprietary Names

Upper Arm Blood Pressure Monitor( Model:BUA4000BUS,BUA4075BUS) Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A1B,FDBP-A2B,FDBP-A3B,FDBP-A4B,FDBP-A5B,FDBP-A6B) Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A9,FDBP-A9B,FDBP-A9BL,FDBP-A9BT,FDBP-A9BLT) Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A10,FDBP-A10B,FDBP-A10BL,FDBP-A10BT,FDBP-A10BLT) Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A7,FDBP-A7B,FDBP-A7BL,FDBP-A7BT,FDBP-A7BLT) LOOKEE® UPPER ARM BLOOD PRESSURE MONITOR(Model No.:FDBP-A2,LK-A2) Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A8,FDBP-A8B,FDBP-A8BL,FDBP-A8BT,FDBP-A8BLT) UPPER ARM BLOOD PRESSURE MONITOR(Model No.:FDBP-A4) UPPER ARM BLOOD PRESSURE MONITOR(Model No.:FDBP-A15) VeriSmart Health Wireless Upper Arm Smart Blood Pressure Monitor VSH-B550, Abdominal Fitness Belt, Model FDES107(ED407); Pain Relief Plaster(Model:FDES105,FDES105B,FDES105C,WMTTENS-90J,TENS-90J) TENS/EMS/Massage 3In1 Electrical Stimulators FDES101B Multi-function Mini TENS&EMS device,model FDES106A; Mini TENS&EMS device,model FDES106(ED406); TENS & EMS Pain Therapy Device (Model: WMTTENS-100,WMTTENS-100A); Electrical stimulator (Model: FDES190) TENS & EMS Dual pad (Model:FDES108) TENS & EMS Pain Therapy Device (Model: FDES191,TENS-150J,TENS-150J-CA,WMTTENS-150J) blood pressure cuff FDAC4122 Braun ThermoScan 3 High Speed Compact Ear Thermometer(Model No.:IRT3030,IRT3030AP,IRT3030US,IRT3030EE,IRT3030WE; Braun ThermoScan 3 High Speed Compact Ear Thermometer(Model No.:IRT3030LA,IRT3030EEPBX,IRT3030WEPBX; Braun ThermoScan 4 Braun; Braun ThermoScan® 4 Ear Thermometer IRT3515; Braun ThermoScan® 4 Ear Thermometer IRT3515US,IRT-3515; IRT-3515US Braun ThermoScan® 4 Ear Thermometer(FDIR-V35,BIT3515CTUS) Braun ThermoScan 3 High Speed Compact Ear Thermometer(Model No.:IRT3030US,IRT3030USV1) Braun ThermoScan® 4+ connect(Model:IRT3575,IRT3575US) Upper arm Blood pressure monitor (Model: BUA4000BUS,BUA4075BUS) Upper Arm Blood Pressure Monitor(Model No.: FDBP-A15,FDBP-A16,FDBP-A17,FDBP-A18,FDBP-A19,FDBP-A20,FDBP-A21) Upper Arm Blood Pressure Monitor(Model No.: FDBP-A1,FDBP-A2,FDBP-A3,FDBP-A4,FDBP-A5,FDBP-A6,FDBP-A7) Upper Arm Blood Pressure Monitor(Model No.: FDBP-A8,FDBP-A9,FDBP-A10,FDBP-A11,FDBP-A12,FDBP-A13,FDBP-A14) Upper Arm Blood Pressure Monitor(model number:BPA-800-WT) Upper arm blood pressure monitor (ModelExactFit 1E, BUA4000US) Upper arm blood pressure monitor(Model:ExactFit 2,BUA4050US)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-05-11
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2014-02-12
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2014-02-12
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2022-08-18
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2021-07-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-04-14
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-12-03

Official Correspondent

Liang Cao

US Agent Details

Yue Zhang Business: Clinical Guard Email: yale@clinicalguard.com Phone: (678) 9994508

Related Public Records

Same Entity

FAMIDOC 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
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

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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3006543075	SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI	SHANGHAI, CN
3011912849	BODYTRACE	San Jose, CA, US
3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
3019575688	AKTIIA SA	Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005621440. Last updated year: 2026. Please use registration number 3005621440 when referencing this establishment in official correspondence.