Data / Medical devices / United States / Hubdic Usa Inc

Hubdic Usa Inc: FDA-registered device maker in Carson, CA, United States, 8 510(k) clearances

Name: Hubdic Usa Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hubdic Usa Inc is registered with the FDA (registration 3021635975) in Carson, CA, United States. It lists 13 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 31, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3021635975
Address: 129 Savarona Way, Carson, CA, United States, 90746
Owner or operator: HuBDIC USA INC (10084344)
Roles: Complaint file establishment, Repackager or relabeler
First device listed: September 26, 2022
Registered through: 2026
Brand names listed: BT-200, FE-0161, FE-4601, FE-7207, FE-7208, FE-7301, HEM-5, HGM-100 and more

Devices it lists

Device	Product code	Class	Role	Source
Bottle, Collection, Vacuum	KDQ	2	Complaint file establishment	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Complaint file establishment	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Complaint file establishment	accessdata.fda.gov
Massager, Powered Inflatable Tube	IRP	2	Complaint file establishment	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Complaint file establishment	accessdata.fda.gov
Pump, Breast, Powered	HGX	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Complaint file establishment	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Complaint file establishment	accessdata.fda.gov
System, Monitoring, Perinatal	HGM	2	Complaint file establishment	accessdata.fda.gov
Transducer, Ultrasonic, Obstetric	HGL	2	Complaint file establishment	accessdata.fda.gov
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile	NOB	1	Repackager or relabeler	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
December 31, 2025	K253305	TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)	NUH	Substantially Equivalent	Shenzhen Jiantuo Electronics Co., Ltd.	accessdata.fda.gov
March 3, 2022	K211850	Air Compression Leg Massager (model: FE-7204B)	IRP	Substantially Equivalent	Xiamen Healthpal Electronic Co.,Ltd	accessdata.fda.gov
February 10, 2021	K200675	Hi bebe super (Models BT-150S and BT-150L)	HGX	Substantially Equivalent	Bistos Co., Ltd.	accessdata.fda.gov
January 2, 2019	K181215	Infrared Thermometer	FLL	Substantially Equivalent	Shenzhen Finicare Co., Ltd.	accessdata.fda.gov
June 19, 2013	K131395	TRANSTEK BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.	accessdata.fda.gov
April 2, 2013	K130361	THERMOFINDER; THERMOCARE	FLL	Substantially Equivalent	Hubdic Co., Ltd.	accessdata.fda.gov
November 10, 2010	K101912	THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301	FLL	Substantially Equivalent	Hubdic Co., Ltd.	accessdata.fda.gov
October 4, 2005	K052190	FETAL MONITOR, MODELS BT-300 AND BT-200	HGM	Substantially Equivalent	Bistos Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 31, 2025. 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.