| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00194252845974 | Feature Version 3.x | Cycle Tracking iPhone App (Version 3.0) | LHD | Device, Fertility Diagnostic, Proceptive | U | Cycle Tracking 3.0 | |
| 2 | 00194252845967 | Feature Version 3.x | Cycle Tracking Watch App (Version 3.0) | LHD | Device, Fertility Diagnostic, Proceptive | U | Cycle Tracking 3.0 | |
| 3 | 00194252456804 | Feature version 1.x | Atrial Fibrillation History Feature Watch app | QDB | Photoplethysmograph Analysis Software For Over-The-Counter Use | 2 | Atrial Fibrillation History Feature | |
| 4 | 00194252456798 | Feature version 1.x | Atrial Fibrillation History Feature iPhone app | QDB | Photoplethysmograph Analysis Software For Over-The-Counter Use | 2 | Atrial Fibrillation History Feature | |
| 5 | 00190198909510 | Feature Version 1.x | QDB | Photoplethysmograph Analysis Software For Over-The-Counter Use | 2 | Irregular Rhythm Notifications | ||
| 6 | 00194252456781 | Feature Version 2.x | Irregular Rhythm Notification feature iPhone App (Version 2.0) | QDB | Photoplethysmograph Analysis Software For Over-The-Counter Use | 2 | Irregular Rhythm Notification feature 2.0 | |
| 7 | 00190199649293 | Feature Version 2.x | ECG iPhone App (version 2.0) | QDA | Electrocardiograph Software For Over-The-Counter Use | 2 | ECG 2.0 App | |
| 8 | 00190199649286 | Feature Version 2.x | ECG Watch App (version 2.0) | QDA | Electrocardiograph Software For Over-The-Counter Use | 2 | ECG 2.0 App | |
| 9 | 00190198909534 | Feature Version 1.x | QDA | Electrocardiograph Software For Over-The-Counter Use | 2 | ECG App | ||
| 10 | 00190198909541 | Feature Version 1.x | QDA | Electrocardiograph Software For Over-The-Counter Use | 2 | ECG App | ||
| 11 | 00190198909527 | Feature Version 1.x | QDB | Photoplethysmograph Analysis Software For Over-The-Counter Use | 2 | Irregular Rhythm Notifications |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00810038852720 | FB604 | FB604 | The Fitbit Irregular Rhythm Notifications is a software-only mobile medical appl The 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 usein people under 22 years of age. It is also not intended for use in individuals previouslydiagnosed with AFib. | Fitbit Irregular Rhythm Notifications | FITBIT, INC. |
| 2 | 00194252456804 | Feature version 1.x | Atrial Fibrillation History Feature Watch app | Atrial Fibrillation History Feature | APPLE INC. | |
| 3 | 00194252456798 | Feature version 1.x | Atrial Fibrillation History Feature iPhone app | Atrial Fibrillation History Feature | APPLE INC. | |
| 4 | 00194252456781 | Feature Version 2.x | Irregular Rhythm Notification feature iPhone App (Version 2.0) | Irregular Rhythm Notification feature 2.0 | APPLE INC. | |
| 5 | 00194252456774 | Feature Version 2.x | Irregular Rhythm Notification feature Watch App (Version 2.0) | Irregular Rhythm Notification feature 2.0 | APPLE INC. | |
| 6 | 00190198909527 | Feature Version 1.x | Irregular Rhythm Notifications | APPLE INC. | ||
| 7 | 00190198909510 | Feature Version 1.x | Irregular Rhythm Notifications | APPLE INC. |