FDA Registration
Active
🇺🇸 United States
Linus Health, Inc.
Reg #: 3014174644
·
FEI: 3014174644
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Linus Health, Inc.
- Registration Number
- 3014174644
- FEI Number
- 3014174644
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 280 Summer Street, 10th floor
- City
- Boston
- State
- MA
- ZIP
- 02210
- Country
- US
Owner / Operator
- Firm Name
- Linus Health, Inc.
- Operator Number
- 10056593
- Address
- 280 Summer Street, 10th Floor
- City
- Boston
- State
- MA
- Postal Code
- 02210
- Country
- US
- Correspondent
- Micah Iberosi-Parnell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Pressure Measurement, Intermittent | JFC | Class 1 | Physical Medicine | No | 2026-04-06 |
| Fall Prevention Alarm/Sensor Attached Only | PJP | Class 1 | General Hospital | No | 2026-04-06 |
| Computerized Cognitive Assessment Aid, Exempt | PTY | Class 2 | Neurology | No | 2017-12-22 |
Proprietary Names
Kinesis Balance
Kinesis GAIT
Linus Health Clinical Platform
Linus Health Platform
Establishment Types
Manufacture Medical Device