Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710548

FEI Number

3003515005

Entity Name

RADIANT INNOVATION INC.

City/State/Country

HSINCHU, TW

Establishment Address

1F, NO.3, INDUSTRIAL E. 9TH RD, SCIENCE-BASED INDUSTRIAL PARK, HSINCHU 30075, TW

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

RADIANT INNOVATION, INC. (Owner Number: 9045429)

Owner / Operator Contact Address

1F,NO. 3,INDUSTRIAL E. 9TH RD, SCIENCE-BASED INDUSTRIAL PARK, HSINCHU, TW-NOTA 300, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111637

PMA Number

N/A

All Registered Proprietary Names

Thermometer, Model TH01BN continuous measurement thermometer - ThermoWorks WAND Cinical; ThermoWorks WAND Mini Infrared Ear Thermometer, Model: THP86JE, THP86JEU, THR96JE, THR86JE, TH809J, MDS9700 Non-contact Forehead Thermometer, Model: THD2FE, TH48FE, TH09F Probe Cover: PC 7200, PC 840, MDSM3A7208058 Non-Contact Clinical Thermometer, Model THD2FE WAND Clinical Non-Contact, Digital Forehead Thermometer, Model TX-5710 Non-Contact Clinical Thermometer, Model TH09F WAND Mini Non-Contact, Digital Forehead Thermometer, Model TX-5700 Non-Contact Clinical Thermometer, Model TH48FE INFRARED EAR THERMOMETER Various names and Models Infrared Ear Thermometer, Model THW07N Infrared Ear Thermometer, Model THWB7N Thermometer, Model THXXN series Thermometer, Model TH88 series Tommee Tippee Digital Ear Thermometer Hygiene Covers, PC840 Tommee Tippee Digital Ear Thermometer, TH889SE Infrared Ear Thermometer, TH819SJE Thermometer, Model TH5XY series MC-521 Infrared Ear Thermometer, Model TH709L Thermometer, electronic, clinical THP79JU Infrared Ear Thermometer, Model THP59JB Infrared Ear Thermometer, Model THP59JU Infrared Ear Thermometer, Model THP79JB Infrared Ear Thermometer, Model THP89JB Infrared Ear Thermometer, Model THP59J

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	2007-11-25
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2025-09-08
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-06-12
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2010-11-17
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-11-25
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-11-25
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-11-25
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2011-03-02
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2011-12-22

Official Correspondent

No official correspondent registered.

US Agent Details

ALAN Schwartz Business: MDI CONSULTANTS, INC. Email: ALAN@MDICONSULTANTS.COM Phone: (516) 4829001

Related Public Records

Same Entity

RADIANT INNOVATION, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004026659	KUNSHAN RADIANT INNOVATION CO., LTD.	JIANGSU PROVINCE, CN

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

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3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710548. Last updated year: 2026. Please use registration number 9710548 when referencing this establishment in official correspondence.