FDA Registration
Active
🇺🇸 United States
AURA WELLNESS, LLC
Reg #: 3018608545
·
FEI: 3018608545
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- AURA WELLNESS, LLC
- Registration Number
- 3018608545
- FEI Number
- 3018608545
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2208 Plantside Drive
- City
- Louisville
- State
- KY
- ZIP
- 40299
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250896
Owner / Operator
- Firm Name
- Aura Wellness, LLC
- Operator Number
- 10081462
- Address
- 2208 Plantside Drive
- City
- Louisville
- State
- KY
- Postal Code
- 40299
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2026-04-02 |
| Electromagnetic Stimulator For Healthy Muscle Stimulation | SGT | Class 2 | Physical Medicine | No | 2025-12-03 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2023-08-24 |
Proprietary Names
Aura Wellness ROC
Aura Wave
Nova HD+
Establishment Types
Manufacture Medical Device