FDA Registration
Active
🇺🇸 United States
BODYTRACE
Reg #: 3011912849
·
FEI: 3011912849
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- BODYTRACE
- Registration Number
- 3011912849
- FEI Number
- 3011912849
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2150 N. First St, Unit 469
- City
- San Jose
- State
- CA
- ZIP
- 95131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190507
Owner / Operator
- Firm Name
- BODYTRACE, INC.
- Operator Number
- 10054678
- Address
- 2150 N. First St, Unit 469
- City
- San Jose
- State
- CA
- Postal Code
- 95131
- Country
- US
- Correspondent
- AMIT GHIA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2026-04-20 |
Proprietary Names
BT108B
BT108A
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility