FDA Registration
Active
🇺🇸 United States
iHealth Labs, Inc.
Reg #: 3008787503
·
FEI: 3008787503
·
Expires 2026
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- iHealth Labs, Inc.
- Registration Number
- 3008787503
- FEI Number
- 3008787503
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 880 W Maude Ave
- City
- Sunnyvale
- State
- CA
- ZIP
- 94085
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243146
Owner / Operator
- Firm Name
- iHealth labs Inc
- Operator Number
- 10078949
- Address
- 880 W Maude Ave
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94085
- Country
- US
- Correspondent
- Yange Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2026-04-30 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2026-04-30 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2026-04-30 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2026-04-30 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2026-04-30 |
Proprietary Names
Unified Care+
Establishment Types
Manufacture Medical Device