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Golden Smart Home Technology Corp.: FDA-registered device maker in Hsinchu City Hsinchu(City), Taiwan, 5 510(k) clearances

Name: Golden Smart Home Technology Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Golden Smart Home Technology Corp. is registered with the FDA (registration 3015188281) in Hsinchu City Hsinchu(City), Taiwan. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 17, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015188281
Address: Room 206, No.47, Yuanqu 2nd Rd. Hsinchu Science Park, Hsinchu City Hsinchu(City), Taiwan, 30075
Owner or operator: Golden Smart Home Technology Corp. (10060061)
Roles: Manufacturer
First device listed: July 2, 2019
Registered through: 2026
Brand names listed: Automatic Arm Bluetooth Blood Pressure Monitor GSH862, WowGoHealth Blood Glucose Monitoring System GSH-BGM902, WowGoHealth Blood Glucose Test Strips - GSH-BGM902 - 2*25, WowGoHealth Bluetooth Body Fat Analyzer GSH231 Series, WowGoHealth Control Solution - GSH-BGM902 - Level 1, WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301, WowGoHealth Infrared Ear & Forehead Thermometer GSH-351, WowGoHealth Pulse Oximeter GSH601

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Body Composition, Exempt	PUH	2	Manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Manufacturer	accessdata.fda.gov
Glucose Dehydrogenase, Glucose	LFR	2	Manufacturer	accessdata.fda.gov
Oximeter, Infrared, Sporting, Aviation	OCH	2	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Manufacturer	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 17, 2023	K220276	Infrared Thermometer TET-351	FLL	Substantially Equivalent	Truly Instrument Limited	accessdata.fda.gov
September 15, 2017	K171785	WowGoHealth Blood Glucose Monitoring System	NBW	Substantially Equivalent	Biotest Medical Corporation	accessdata.fda.gov
October 24, 2016	K161846	Automatic Arm Bluetooth Blood Pressure Monitor	DXN	Substantially Equivalent	Truly Instrument Limited	accessdata.fda.gov
May 19, 2015	K141351	SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM	NBW	Substantially Equivalent	Biotest Medical Corp.	accessdata.fda.gov
January 6, 2012	K110559	AVITA INFRARED THEROMETER WITH BLUETOOTH	FLL	Substantially Equivalent	Avita Corporation	accessdata.fda.gov

Compare with other makers

Updated February 17, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.