FDA Registration
Active
🇺🇸 United States
ENCORA, INC
Reg #: 3043526479
·
FEI: 3043526479
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ENCORA, INC
- Registration Number
- 3043526479
- FEI Number
- 3043526479
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 311 Summer St Ste 200
- City
- Boston
- State
- MA
- ZIP
- 02210
- Country
- US
Regulatory Submissions
- 510(k) Number
- K251517
Owner / Operator
- Firm Name
- Encora, Inc
- Operator Number
- 10095316
- Address
- 311 Summer St, Suite 200
- City
- Boston
- State
- MA
- Postal Code
- 02210
- Country
- US
- Correspondent
- Allison Davanzo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| External Upper Limb Tremor Stimulator | QBC | Class 2 | Neurology | No | 2026-02-25 |
Proprietary Names
Encora X1
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility