Data / Medical devices / United States / Bear Down Brands, LLC Chino Warehouse
Bear Down Brands, LLC Chino Warehouse: FDA-registered device maker in Chino, CA, United States, 9 510(k) clearances
Bear Down Brands, LLC Chino Warehouse is registered with the FDA (registration 3028172072) in Chino, 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.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3028172072
- Address
- 5985 Schaefer Ave, Chino, CA, United States, 91710
- Owner or operator
- Bear Down Brands, LLC (10047275)
- Roles
- Complaint file establishment, Repackager or relabeler
- 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, Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Device, Medical Examination, Ac Powered | KZF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| 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
- All makers of Device, Medical Examination, Ac Powered
- All makers of Toothbrush, Powered
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Pad, Heating, Powered
- All makers of Clinical Electronic Thermometer
- All makers of Continuous Measurement Thermometer
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.