FDA Registration
Active
🇺🇸 United States
FITBIT LLC
Reg #: 3009253624
·
FEI: 3009253624
·
Expires 2026
Products
6
Proprietary Names
8
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- FITBIT LLC
- Registration Number
- 3009253624
- FEI Number
- 3009253624
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 215 Fremont St
- City
- San Francisco
- State
- CA
- ZIP
- 94105
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN230050
Owner / Operator
- Firm Name
- Fitbit LLC
- Operator Number
- 10040574
- Address
- 215 Fremont Street
- City
- San Francisco
- State
- CA
- Postal Code
- 94105
- Country
- US
- Correspondent
- Jeanie Phan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Body Temperature Sensing Software | QZA | Class 2 | General Hospital | No | 2024-01-10 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2017-10-05 |
| Electrocardiograph Software For Over-The-Counter Use | QDA | Class 2 | Cardiovascular | No | 2020-09-21 |
| Photoplethysmograph Analysis Software For Over-The-Counter Use | QDB | Class 2 | Cardiovascular | No | 2022-04-13 |
| Loss Of Pulse Notification Software | SDY | Class 2 | Cardiovascular | No | 2025-03-14 |
| Analyzer, Body Composition | MNW | Class 2 | Cardiovascular | No | 2014-07-30 |
Proprietary Names
Fitbit Aria 2 WiFi Smart Scale
Google ECG App
Fitbit ECG App
Fitbit Irregular Rhythm Notifications
Google Irregular Rhythm Notifications
Body Temperature Software
Loss of Pulse Detection
Fitbit Aria WiFi Smart Scale
Establishment Types
Manufacture Medical Device