FDA Registration
Active
🇺🇸 United States
BEAR DOWN BRANDS, LLC
Reg #: 3011077581
·
FEI: 3011077581
·
Expires 2026
Products
14
Proprietary Names
1
Establishment Types
2
Classifications
14
Registration Details
- Registration Name
- BEAR DOWN BRANDS, LLC
- Registration Number
- 3011077581
- FEI Number
- 3011077581
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1938 W Malvern Ave
- City
- Fullerton
- State
- CA
- ZIP
- 92833
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223308
Owner / Operator
- Firm Name
- Bear Down Brands, LLC
- Operator Number
- 10047275
- Address
- 1930-1938 Malvern Ave
- City
- Fullerton
- State
- CA
- Postal Code
- 92833
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2026-06-11 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2020-01-30 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2023-08-04 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2023-08-04 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2022-05-10 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2022-05-04 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2022-11-17 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2022-12-15 |
| Media, Electroconductive | GYB | Class 2 | Neurology | No | 2022-12-15 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2022-05-04 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2019-07-12 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2019-01-24 |
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2019-10-12 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2021-03-17 |
Proprietary Names
PEPNGN
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility