| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand 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. | QDB | Photoplethysmograph Analysis Software For Over-The-Counter Use | 2 | Fitbit Irregular Rhythm Notifications |
| 2 | 00816137020831 | FB202 | FB202WT | The Aria 2 Wireless Smart Scale is a body analyzer that measures body weight and The Aria 2 Wireless Smart Scale is a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat percentage in generally healthy individuals 13 years of age or older. It is intended for home use only. | PUH | Analyzer, Body Composition, Exempt | 2 | Aria 2 Wi-Fi Smart Scale |
| 3 | 00816137020800 | FB202 | FB202BK | The Aria 2 Wireless Smart Scale is a body analyzer that measures body weight and The Aria 2 Wireless Smart Scale is a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat percentage in generally healthy individuals 13 years of age or older. It is intended for home use only. | PUH | Analyzer, Body Composition, Exempt | 2 | Aria 2 Wi-Fi Smart Scale |
| 4 | 00810038851983 | FB603 | The Fitbit ECG App is a software-only mobile medical application intended for us The 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 isintended 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 | QDA | Electrocardiograph Software For Over-The-Counter Use | 2 | Fitbit ECG App | |
| 5 | 00810351028895 | FB201B2 | FB201B2 | The ARIA WiFi Smart Scale uses the Bioelectrical Impedance Analysis (BIA) techni The ARIA WiFi Smart Scale uses the Bioelectrical Impedance Analysis (BIA) technique to measure body fat composition by sending a low, safe electrical current throughout the body (“foot-to-foot”). The current passes through muscle tissue with lower resistance than through fat tissue. The resistance in fat tissue is termed “bioelectrical impedance” and is the principle of operation for the ARIA scale measurement. The ARIA scale displays the measurement results to the user on a large display that is backlit and easy to read from the standing position. Measurement results include body weight (lb, kg, stone) and body fat (percentage). The scale stores up to 16 readings. The scale is battery operated (4-AA batteries). Prior to use, the user creates a confidential profile on the Fitbit website (which is only available to the user unless affirmatively shared by the user with other users). The scale has an added functionality of wirelessly transmitting the readings to the user’s profile for trending. The user profile is stored locally on the scale, so that the functionality of the scale is autonomous after initial setup.Up to eight (8) users may create profiles to use a single scale. The scale has an automatic recognition function, where it recognizes the user based on the user’s previous weight and profile. If two users have similar body weight profiles, they will be prompted to identify themselves using their initials at the time of weight measurement (selection by tapping the appropriate side of the scale).The complementary interface with the Fitbit website allows the user to view their body weight and body fat trend data over time. | MNW | Analyzer, Body Composition | 2 | Aria |
| 6 | 00898628002045 | FB201B | FB201B | The ARIA WiFi Smart Scale uses the Bioelectrical Impedance Analysis (BIA) techni The ARIA WiFi Smart Scale uses the Bioelectrical Impedance Analysis (BIA) technique to measure body fat composition by sending a low, safe electrical current throughout the body (“foot-to-foot”). The current passes through muscle tissue with lower resistance than through fat tissue. The resistance in fat tissue is termed “bioelectrical impedance” and is the principle of operation for the ARIA scale measurement. The ARIA scale displays the measurement results to the user on a large display that is backlit and easy to read from the standing position. Measurement results include body weight (lb, kg, stone) and body fat (percentage). The scale stores up to 16 readings. The scale is battery operated (4-AA batteries). Prior to use, the user creates a confidential profile on the Fitbit website (which is only available to the user unless affirmatively shared by the user with other users). The scale has an added functionality of wirelessly transmitting the readings to the user’s profile for trending. The user profile is stored locally on the scale, so that the functionality of the scale is autonomous after initial setup.Up to eight (8) users may create profiles to use a single scale. The scale has an automatic recognition function, where it recognizes the user based on the user’s previous weight and profile. If two users have similar body weight profiles, they will be prompted to identify themselves using their initials at the time of weight measurement (selection by tapping the appropriate side of the scale).The complementary interface with the Fitbit website allows the user to view their body weight and body fat trend data over time. | MNW | Analyzer, Body Composition | 2 | Aria |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 06971627020167 | CW286BLE | Analyzer,Body composition | SHENZHEN UNIQUE SCALES CO., LTD | ||
| 2 | 06971627020150 | CF391BLE | Analyzer,Body composition | SHENZHEN UNIQUE SCALES CO., LTD | ||
| 3 | 06971627020136 | CF395BLE | Analyzer,Body composition | SHENZHEN UNIQUE SCALES CO., LTD | ||
| 4 | 06971627020129 | CF369BLE | Analyzer,Body composition | SHENZHEN UNIQUE SCALES CO., LTD | ||
| 5 | 06971627020112 | CF509BLE | Analyzer,Body composition | SHENZHEN UNIQUE SCALES CO., LTD | ||
| 6 | 06971627020105 | CF376BLE | Analyzer,Body composition | SHENZHEN UNIQUE SCALES CO., LTD | ||
| 7 | 06970651384658 | TT-FS001 | TAOTRONICS Wireless Body Composition Smart Scale | SHENZHEN NEARBYEXPRESS TECHNOLOGY DEVELOPMENT COMPANY LIMITED | ||
| 8 | 06954644457826 | 578240733FW | 5782F | Metro | CONMO ELECTRONIC CO., LTD | |
| 9 | 06954644457802 | 578040733FW | 5780FA | Taylor | CONMO ELECTRONIC CO., LTD | |
| 10 | 06954644457710 | 57714192F/577141933F | 5771FA | Taylor | CONMO ELECTRONIC CO., LTD | |
| 11 | 06954644457321 | 57324102FB/57324102FT | 5732FA | Taylor | CONMO ELECTRONIC CO., LTD | |
| 12 | 06947679701170 | SF1400B | IGuerburn | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. | ||
| 13 | 06947468554796 | T9140 | Eufy | SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TECHNOLOGY CO., LTD. | ||
| 14 | 06947468544575 | T9143 | efuy | SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TECHNOLOGY CO., LTD. | ||
| 15 | 06947468544568 | T9140 | eufy | SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TECHNOLOGY CO., LTD. | ||
| 16 | 06947468500380 | SF-371 | belter | SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TECHNOLOGY CO., LTD. | ||
| 17 | 05060502140050 | MultiScan 5000 | Bodystat MultiScan 5000 Body Composition & Fluid Monitoring Unit using Bioelectr Bodystat MultiScan 5000 Body Composition & Fluid Monitoring Unit using Bioelectrical Impedance | Bodystat | BODYSTAT LTD | |
| 18 | 05060502140043 | QuadScan 4000 | Bodystat QuadScan 4000 Body Composition & Fluid Monitoring Unit using Bioelectri Bodystat QuadScan 4000 Body Composition & Fluid Monitoring Unit using Bioelectrical Impedance Analysis (BIA) | Bodystat | BODYSTAT LTD | |
| 19 | 05060502140036 | 1500MDD | Bodystat 1500MDD Body Composition & Fluid Monitoring Unit using Bioelectrical Im Bodystat 1500MDD Body Composition & Fluid Monitoring Unit using Bioelectrical Impedance Analysis (BIA) | Bodystat | BODYSTAT LTD | |
| 20 | 05060502140029 | 1500 | Bodystat 1500 Body Composition Monitoring Unit using Bioelectrical Impedance Ana Bodystat 1500 Body Composition Monitoring Unit using Bioelectrical Impedance Analysis (BIA) | Bodystat | BODYSTAT LTD | |
| 21 | 04904785022713 | MC-780U | TANITA Multi- Frequency Body Composition Analyzer | TANITA CORPORATION | ||
| 22 | 04904785817821 | UM-081 | TANITA Body Fat Monitor | TANITA CORPORATION | ||
| 23 | 04904785817814 | RD-901 | RD-901 WH | TANITA/Ironman Body Composition Monitor | TANITA CORPORATION | |
| 24 | 04904785817807 | RD-901 | RD-901 BK | TANITA/Ironman Body Composition Monitor | TANITA CORPORATION | |
| 25 | 04904785817791 | BF-684W | TANITA Body Fat Monitor | TANITA CORPORATION | ||
| 26 | 04904785817784 | BF-683P | TANITA Body Fat Monitor | TANITA CORPORATION | ||
| 27 | 04904785817777 | BF-680W | TANITA Body Fat Monitor | TANITA CORPORATION | ||
| 28 | 04904785817760 | BF-679W | TANITA Body Fat Monitor | TANITA CORPORATION | ||
| 29 | 04904785817753 | BF-679F | TANITA/FitScan Body Fat Monitor | TANITA CORPORATION | ||
| 30 | 04904785817746 | BC-585P | TANITA/FitScan Body Composition Monitor | TANITA CORPORATION | ||
| 31 | 04904785817739 | BC-585F | TANITA/FitScan Body Composition Monitor | TANITA CORPORATION | ||
| 32 | 04904785817722 | BC-577F | TANITA/FitScan Body Composition Monitor | TANITA CORPORATION | ||
| 33 | 04904785817715 | BC-554 | TANITA/Ironman Body Composition Monitor | TANITA CORPORATION | ||
| 34 | 04904785817708 | BC-549plus | TANITA/Ironman Body Composition Monitor | TANITA CORPORATION | ||
| 35 | 04904785817692 | BC-549 | TANITA/Ironman Body Composition Monitor | TANITA CORPORATION | ||
| 36 | 04904785817685 | BC-534P | TANITA Body Composition Monitor | TANITA CORPORATION | ||
| 37 | 04904785817678 | BC-533 | TANITA Body Composition Monitor | TANITA CORPORATION | ||
| 38 | 04904785817661 | BC-601FS | TANITA/FitScan Body Composition Monitor | TANITA CORPORATION | ||
| 39 | 04904785817654 | BC-601F | TANITA/FitScan Body Composition Monitor | TANITA CORPORATION | ||
| 40 | 04904785817647 | BC-568 | TANITA Body Composition Monitor | TANITA CORPORATION | ||
| 41 | 04904785817630 | BC-558 | TANITA/Ironman Body Composition Monitor | TANITA CORPORATION | ||
| 42 | 04904785817623 | BC-350 | TANITA/Ironman Body Composition Monitor | TANITA CORPORATION | ||
| 43 | 04904785817616 | BC-1500 | TANITA/Ironman Body Composition Monitor | TANITA CORPORATION | ||
| 44 | 04904785817609 | BC-1000plus | BC-1000plus WH | TANITA Body Composition Monitor | TANITA CORPORATION | |
| 45 | 04904785817593 | BC-1000plus | BC-1000plus BK | TANITA Body Composition Monitor | TANITA CORPORATION | |
| 46 | 04904785172036 | MC-980U plus | MC-980U plus RD | TANITA Multi-Frequency Body Composition Analyzer | TANITA CORPORATION | |
| 47 | 04904785060012 | MC-980U plus | TANITA Multi- Frequency Body Composition Analyzer | TANITA CORPORATION | ||
| 48 | 04904785060005 | BF-350 | TANITA Body Composition Analyzer | TANITA CORPORATION | ||
| 49 | 04904785029118 | TBF-400 | TANITA Body Composition Analyzer | TANITA CORPORATION | ||
| 50 | 04904785029101 | TBF-410GS | TANITA Body Composition Analyzer | TANITA CORPORATION |