FUDAKANG INDUSTRIAL CO LTD

FDA Device Registration & Listing · Dongguan Guangdong, CN · Registration 3008167616

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008167616
FEI Number
3008167616
Entity Name
FUDAKANG INDUSTRIAL CO LTD
City/State/Country
Dongguan Guangdong, CN
Establishment Address
501, Building 2, No. 11 Changheng Road,, Changping Town, Dongguan Guangdong 523560, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Fudakang Industrial Co Ltd (Owner Number: 10031413)
Owner / Operator Contact Address
501, Building 2, No. 11 Changheng Road,, Changping Town, Dongguan, CN-GD 523560, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K150430
PMA Number
N/A

All Registered Proprietary Names

Premom: EBT-380 PREX: BT-A31 shecare:BT-A31, YC-K889B easy @home: EBT-380 (TP500), EBT-089, EBT-300 FDK: BT-A31-BT, BT-A41CN-BT Glow: UO-8064 FDK Infrared Thermometer W/BLUETHOTH:: FT-F11-BT TysonBio Infrared Thermometer W/BLUETHOTH:NC100 TysonBio Thermomter with bluetooth without display: TP-100, TP-200, TP-300, TP-400, TP-500 FDK Thermomter with bluetooth without display: BT-A31A-BT Uone(HK)Industrial Co.,Limited: UO-8080,UO-8080E FDK Infrared Thermometer: FT-F11, FT-F21, FT-F31,FT-F41, FT-F41A, FT-F42, FT-F15, FT-F33 AUPO: FT-F21 FDK: FT-F41 REIZEN infrared Thermometer: FT-F31 (381315) Arrotemp: FT-F31 (P-108425) ADVOCATE: FT-F31 (ASPT-01) dr.Madre: FT-F31 (DRM-22) Clinical Electronic Thermometer FDK: BT-A11CN, BT-A21CN, BT-A41CN, BT-A13 Easy@Home Smart Basal Thermometer: EBT-300 Easy@Home Digital Basal Thermometer: EBT-100, EMT-A12 Premom Smart Basal Thermometer: EBT-380 FDK Electronic Blood Pressure Monitor Arm Type : FT-C26Y-V FDK WRIST CUFF BPM W/BLUETHOTH & UART ( NO VOICE): FT-B13W-BT FDK WRIST CUFF BPM: FT-B31Y FDK ARM CUFF BPM W/NO VOICE: FT-C11B, FT-C12B, FT-C03B, FT-C15B, FT-C22Y, FT-C23Y, FT-C24Y, FT-C26Y FDK ARM CUFF BPM W/BLUETHOTH: FT-C11B-BT Blue Jay Arm & Wrist BPM:FT-C06(BJ120108), FT-B12W(BJ120110) FDK ARM CUFF BPM W/VOICE: FT-C03-V, FT-C03B-V, FT-C11B-V, FT-C12B-V, FT-C15Y-V, FT-C22Y-V, FT-C23Y-V, FT-C24Y-V FDK WRIST CUFF BPM W/BLUETHOTH & UART ( VOICE): FT-B13W-V-BT Sunbeam Wrist BPM : FT-B06W-V & FT-B06W AUPO WRIST CUFF BPM:FT-B13W ChoiceMMed Arm&Wrist BPM: FT-C11B(MDBP12), FT-B12W(BP201) FDK ARM CUFF BLOOD PRESSURE MONITOR: FT-C15B FDK Electronic Blood Pressure Monitor Arm Type : FT-C15Y FDK Electronic Blood Pressure Monitor Arm Type : FT-C24Y FDK Electronic Blood Pressure Monitor Wrist Type : FT-B14W FDK ARM CUFF SPEAKING BLOOD PRESSURE MONITOR: FT-C03-V Proactive Blood Pressure Monitor Arm Type : PMDBPA (FT-C21Y)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-09-23
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-09-23
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2018-06-11
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2012-04-06
SDV Clinical Electronic Thermometer General Hospital Class 2 880.2910 2025-07-07
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-04-20

Official Correspondent

Bob Yu

US Agent Details

Jephanie Chen Business: Fudakang Industrial Inc. Email: jephanie@fdkmedical.com Phone: (725) 7266008

Related Public Records

Same Entity

Fudakang Industrial 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
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
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23
K842199 Sharp Electronics Corp. ELEC. DIGITAL THERMOMETER MT-20 & 30 1984-07-18

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008167616. Last updated year: 2026. Please use registration number 3008167616 when referencing this establishment in official correspondence.
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