| Primary Device ID | 00810038852720 |
| NIH Device Record Key | a8b73ee3-6fb0-41e1-888f-e32d0869c7cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fitbit Irregular Rhythm Notifications |
| Version Model Number | FB604 |
| Catalog Number | FB604 |
| Company DUNS | 829454672 |
| Company Name | FITBIT, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| 00810038852720 - Fitbit Irregular Rhythm Notifications | 2022-05-03The Fitbit Irregular Rhythm Notifications is a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provide a notification to the user.
The Fitbit Irregular Rhythm Notifications is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the Fitbit Irregular Rhythm Notifications is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis.
These data are only captured when the user is still. Along with the user’s risk factors, the Fitbit Irregular Rhythm Notifications can be used to supplement the decision for AFib screening. The Fitbit Irregular Rhythm Notifications is not intended to replace traditional methods of diagnosis or treatment.
The Fitbit Irregular Rhythm Notifications has not been tested for and is not intended for use
in people under 22 years of age. It is also not intended for use in individuals previously
diagnosed with AFib. |
| 00810038852720 - Fitbit Irregular Rhythm Notifications | 2022-05-03 The Fitbit Irregular Rhythm Notifications is a software-only mobile medical application that is intended to be used with compati |
| 00810038851983 - Fitbit ECG App | 2020-10-15 The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, |
| 00810351028895 - Aria | 2018-10-31 The ARIA WiFi Smart Scale uses the Bioelectrical Impedance Analysis (BIA) technique to measure body fat composition by sending a |
| 00816137020800 - Aria 2 Wi-Fi Smart Scale | 2018-03-29 The Aria 2 Wireless Smart Scale is a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) tec |
| 00816137020831 - Aria 2 Wi-Fi Smart Scale | 2018-03-29 The Aria 2 Wireless Smart Scale is a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) tec |