FDA Registration
Active
🇺🇸 United States
AVACEN 100
Reg #: 3009668937
·
FEI: 3009668937
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AVACEN, INC.
- Registration Number
- 3009668937
- FEI Number
- 3009668937
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6451 El Camino Real Ste C
- City
- Carlsbad
- State
- CA
- ZIP
- 92009
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133981
Owner / Operator
- Firm Name
- AVACEN, Inc.
- Operator Number
- 10041019
- Address
- 6451 El Camino Real, Suite C
- City
- Carlsbad
- State
- CA
- Postal Code
- 92009
- Country
- US
- Correspondent
- Thomas G Muehlbauer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2014-08-18 |
Proprietary Names
AVACEN 100
AVACEN HOME XL
AVACEN HOME
AVACEN PRO
AVACEN PRO+
Establishment Types
Manufacture Medical Device