BEAR DOWN BRANDS, LLC

FDA Device Registration & Listing · Fullerton, CA, US · Registration 3011077581

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
3011077581
FEI Number
3011077581
Entity Name
BEAR DOWN BRANDS, LLC
City/State/Country
Fullerton, CA, US
Establishment Address
1938 W Malvern Ave, Fullerton, CA 92833, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Bear Down Brands, LLC (Owner Number: 10047275)
Owner / Operator Contact Address
1930-1938 Malvern Ave, Fullerton, CA 92833, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K151284
PMA Number
N/A

All Registered Proprietary Names

PEPNGN

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
SDV Clinical Electronic Thermometer General Hospital Class 2 880.2910 2026-06-11
KFZ Humidifier, Non-Direct Patient Interface (Home-Use) Anesthesiology Class 1 868.5460 2020-01-30
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2023-08-04
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2023-08-04
KZF Device, Medical Examination, Ac Powered General Hospital Class 1 880.6320 2022-05-10
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2022-05-04
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2022-05-04
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2022-11-17
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2019-01-24
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2022-12-15
GYB Media, Electroconductive Neurology Class 2 882.1275 2022-12-15
NYN Stimulator, Electrical, Transcutaneous, For Arthritis Neurology Class 2 882.5890 2022-05-04
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2022-05-04
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2022-05-04
JEQ Toothbrush, Powered Dental Class 1 872.6865 2019-07-12
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2020-04-21
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2019-01-24
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2020-04-21
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2019-10-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bear Down Brands, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3028172072 BEAR DOWN BRANDS, LLC CHINO WAREHOUSE Chino, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K881862 Thermo Body Wrap Systems, Inc. THERMO-BODY-WRAP SYSTEM 1988-10-13
K851742 Burton Medical Products Corp. MEDICAL EXAMINATION LIGHTS 1985-05-13
K221200 Xbody Hungary Kft. XBody Go USA, XBody Pro USA 2023-01-31
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24

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3007499349 VERIDIAN HEALTHCARE Gurnee, IL, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011077581. Last updated year: 2026. Please use registration number 3011077581 when referencing this establishment in official correspondence.
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