Data / Medical devices / United States / Bear Down Brands, LLC

Bear Down Brands, LLC: FDA-registered device maker in Fullerton, CA, United States, 9 510(k) clearances

Name: Bear Down Brands, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bear Down Brands, LLC is registered with the FDA (registration 3011077581) in Fullerton, CA, United States. It lists 14 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 13, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011077581
Address: 1938 W Malvern Ave, Fullerton, CA, United States, 92833
Owner or operator: Bear Down Brands, LLC (10047275)
Roles: Complaint file establishment, Specification developer
First device listed: January 24, 2019
Registered through: 2026
Brand names listed: PEPNGN

Devices it lists

Device	Product code	Class	Role	Source
Clinical Electronic Thermometer	SDV	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Device, Medical Examination, Ac Powered	KZF	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Humidifier, Non-Direct Patient Interface (Home-Use)	KFZ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Media, Electroconductive	GYB	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Pad, Heating, Powered	IRT	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Pump, Breast, Powered	HGX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	Complaint file establishment, Specification developer	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
May 13, 2023	K223308	HEATING TENS/EMS, FT-810R	NUH	Substantially Equivalent	Hivox Biotek, Inc.	accessdata.fda.gov
June 11, 2022	K221384	Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2	NUH	Substantially Equivalent	Hivox Biotek, Inc.	accessdata.fda.gov
December 21, 2015	K151284	Electric Double Breast Pumps	HGX	Substantially Equivalent	Wuxi Xinzhongrui Baby Supplies Co., Ltd.	accessdata.fda.gov
November 14, 2014	K141299	OTC COMBO TENS/EMS SYSTEM	NUH	Substantially Equivalent	Well-Life Healthcare Limited	accessdata.fda.gov
July 25, 2014	K131720	HIVOX SELF ADHESIVE ELECTRODE GEL PADS	GXY	Substantially Equivalent	Hivox Biotek, Inc.	accessdata.fda.gov
November 15, 2013	K131921	ELECTRONIC PULSE STIMULATOR	NUH	Substantially Equivalent	Shenzhen Jingkehui Electronic Co.., Ltd.	accessdata.fda.gov
February 5, 2010	K091757	OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407	NUH	Substantially Equivalent	Well-Life Healthcare Limited	accessdata.fda.gov
December 2, 2009	K092958	AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES	FLL	Substantially Equivalent	Avita Corporation	accessdata.fda.gov
April 10, 2009	K082065	WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP	GXY	Substantially Equivalent	Well-Life Healthcare Limited	accessdata.fda.gov

Compare with other makers

Updated May 13, 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.