| Primary Device ID | 00810038851983 |
| NIH Device Record Key | 5002e376-4e5d-4697-9a47-c813f290adfc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fitbit ECG App |
| Version Model Number | FB603 |
| 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 |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com | |
| Phone | +1(877) 623-4997 |
| support@fitbit.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810038851983 [Primary] |
| QDA | Electrocardiograph Software For Over-The-Counter Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-15 |
| Device Publish Date | 2020-10-07 |
| 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 | 2020-10-15The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias. The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Spot Check is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old |
| 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 |