FDA Registration
Active
🇺🇸 United States
Cala Trio
Reg #: 3011628389
·
FEI: 3011628389
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CALA HEALTH, INC.
- Registration Number
- 3011628389
- FEI Number
- 3011628389
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1800 Gateway Drive Suite 120
- City
- Foster City
- State
- CA
- ZIP
- 94404
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203288
Owner / Operator
- Firm Name
- Cala Health, Inc.
- Operator Number
- 10061278
- Address
- 1800 Gateway Drive Suite 120
- City
- San Mateo
- State
- CA
- Postal Code
- 94404
- Country
- US
- Correspondent
- Regulatory Affairs Cala Health
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| External Upper Limb Tremor Stimulator | QBC | Class 2 | Neurology | No | 2022-12-09 |
Proprietary Names
Cala Trio
Establishment Types
Manufacture Medical Device