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 | 00857817000880 | USHM180G | Digital Body Fat/Water Scale, Retail Packaging | Escali | ESCALI CORP | |
2 | 00854894005173 | B100 | B100-IOW | QardioBase | QARDIO, INC. | |
3 | 00854067005269 | EHS-SDWS | Smart Diabetes Wireless Weight Scale | Eocene | VALUE PROVIDERS LLC | |
4 | 00852547004184 | BF520 | 760.71 | Glass Body Analysis Scale | Beurer | BEURER NORTH AMERICA, L.P. |
5 | 00821793047054 | UA HEALTHBOX (3-in-1 HealthBox Pack) | HTC | HTC AMERICA, INC. | ||
6 | 00821793046880 | UA HEALTHBOX (CS_White) | HTC | HTC AMERICA, INC. | ||
7 | 00821793046842 | UA HEALTHBOX (CS_Black) | HTC | HTC AMERICA, INC. | ||
8 | 00818323029949 | DMD1041 | Digital Scale with Smart Phone Capability | VIVE | VIVE HEALTH LLC | |
9 | 00817746020335 | SW-SBS700 | Body fat scale | BETTER BASICS, INC. | ||
10 | 00817746020304 | SW-SBS500 | Body fat scale | BETTER BASICS, INC. | ||
11 | 00815817012333 | ZB13-W | Bathroom scale body fat analyzer. Support up to 8 users.Scale supports TARE func Bathroom scale body fat analyzer. Support up to 8 users.Scale supports TARE function.Default unit is LB. Units - kg/lb/st.Batteries included. Utilizes 4 high precision GX sensors to weigh up to 440 pounds (200 kilograms) in 0.2 lbs or 0.1 kg increments with Step On technology.Elegant reflective surface is made of high quality impact-resistant tempered glass, which is 4 times stronger than normal glass. Color- White.This scale is not for clinical or diagnostic use. | Ozeri | COMMONPATH LLC | |
12 | 00815817012326 | ZB13 | Default unit is LB. Batteries included. Utilizes 4 high precision GX sensors to Default unit is LB. Batteries included. Utilizes 4 high precision GX sensors to weigh up to 440 pounds (200 kilograms) in 0.2 lbs or 0.1 kg increments with Step On technology.Elegant reflective surface is made of high quality impact-resistant tempered glass, which is 4 times stronger than normal glass. Color- Black.This scale is not for clinical or diagnostic use. | Ozeri | COMMONPATH LLC | |
13 | 00811392021029 | LS206-E | The Profile Smart Body Scale measures weight and uses bioelectrical impedance an The Profile Smart Body Scale measures weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only. | Profile by Sanford | PROFILE PRODUCTS, LLC | |
14 | 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. | Aria | FITBIT, INC. |
15 | 00311917159928 | FG9301 | Digital glass scale with body analysis features. | Well at Walgreens | WALGREEN CO. | |
16 | 00146191288527 | ADF-B885T | ITO Wireless Body Fat Scale | Andnesfit Health | ANDESFIT LIMITED | |
17 | 00080006112549 | BFM600KD-53 | Body Fat Monitoring Scale | Health-O-Meter | JARDEN CONSUMER SOLUTIONS | |
18 | 00080006112518 | BFM149DQ-05 | Body Fat Monitoring Scale | Health-O-Meter | JARDEN CONSUMER SOLUTIONS | |
19 | 00080006112334 | BFM081DQ1-63 | Body Fat Monitoring Scale | Health-O-Meter | JARDEN CONSUMER SOLUTIONS | |
20 | 00080006111955 | 080006111955 | Body Fat Monitoring Scale | Health-O-Meter | JARDEN CONSUMER SOLUTIONS | |
21 | 00080006111849 | BFM145DQ3-63-U | Body Fat Monitoring Scale | Health-O-Meter | JARDEN CONSUMER SOLUTIONS | |
22 | 00080006111825 | 080006111825 | Body Fat Monitoring Scale | Health-O-Meter | JARDEN CONSUMER SOLUTIONS | |
23 | 00077784043073 | 5297054 | Taylor | TAYLOR PRECISION PRODUCTS, INC. | ||
24 | 00077784038963 | MB-02 | 5273275 | Taylor | TAYLOR PRECISION PRODUCTS, INC. | |
25 | 00077784035405 | BS150 | Brookstone | TAYLOR PRECISION PRODUCTS, INC. | ||
26 | 00077784032848 | 5789 | Taylor | TAYLOR PRECISION PRODUCTS, INC. | ||
27 | 00077784032626 | 5737 | 57374072F | Taylor | TAYLOR PRECISION PRODUCTS, INC. | |
28 | 00077784032619 | 5792 | 57924072F | Taylor | TAYLOR PRECISION PRODUCTS, INC. | |
29 | 00077784032602 | 5793 | 57934072F | Taylor | TAYLOR PRECISION PRODUCTS, INC. | |
30 | 00077784031155 | SC-548 | SC-548 | Homedics | TAYLOR PRECISION PRODUCTS, INC. | |
31 | 00077784031117 | 5721 | 572140732F | BODY COMPOSITION ANALYZERS | Taylor | TAYLOR PRECISION PRODUCTS, INC. |
32 | 00077784029824 | 5581F | 55814072F | Taylor | TAYLOR PRECISION PRODUCTS, INC. | |
33 | 00077784029602 | SC-547 | SC-547-4TY | Taylor | TAYLOR PRECISION PRODUCTS, INC. | |
34 | 00077784029503 | 5580F | 55804072N | Taylor | TAYLOR PRECISION PRODUCTS, INC. | |
35 | 00077784029497 | 5592F | 55924102F | Taylor | TAYLOR PRECISION PRODUCTS, INC. | |
36 | 00077784029350 | 5721FW | 572141933FW | Taylor | TAYLOR PRECISION PRODUCTS, INC. | |
37 | 00077784028131 | ESBS-58 | ESBS-58 | EatSmart | TAYLOR PRECISION PRODUCTS, INC. | |
38 | 00077784027943 | 5748F | 57484192F | BODY COMPOSITION ANALYZERS | Taylor | TAYLOR PRECISION PRODUCTS, INC. |
39 | 00077784027837 | 5795F | 57954102F | BODY COMPOSITION ANALYZERS | Taylor | TAYLOR PRECISION PRODUCTS, INC. |
40 | 00077784027615 | 5780F | 578040733FW | Taylor | TAYLOR PRECISION PRODUCTS, INC. | |
41 | 00077784027578 | 5782 | 578240733FW | Metro | TAYLOR PRECISION PRODUCTS, INC. | |
42 | 00077784027561 | 5772F | 57724102F | Taylor | TAYLOR PRECISION PRODUCTS, INC. | |
43 | 00077784027554 | 5771F | 57714192F | Taylor | TAYLOR PRECISION PRODUCTS, INC. | |
44 | 00077784025642 | 5732FT | 57324102FT, 57324102F | Taylor | TAYLOR PRECISION PRODUCTS, INC. | |
45 | 00077784022658 | 5573FT | 55734072FT | Taylor | TAYLOR PRECISION PRODUCTS, INC. | |
46 | 00077784022009 | 5575F | 55754072F | Taylor | TAYLOR PRECISION PRODUCTS, INC. | |
47 | 00077784021675 | SC-544 | SC-544 | Homedics | TAYLOR PRECISION PRODUCTS, INC. | |
48 | 00077784021668 | SC-543 | SC-543 | Homedics | TAYLOR PRECISION PRODUCTS, INC. | |
49 | 00077784021644 | 7224FBOW | 72244072FBOW | Taylor | TAYLOR PRECISION PRODUCTS, INC. | |
50 | 00077784021279 | SC-902 | SC-902 | Taylor | TAYLOR PRECISION PRODUCTS, INC. |