Aria

Primary DI
00810351028895
Brand
Aria
Company
Fitbit LLC
Model
FB201B2
Catalog number
FB201B2
Device description
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.
Published
2016-10-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNWAnalyzer, Body Composition

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNWAnalyzer, Body CompositionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133872000ARIA WIFI SMART SCALEFitbit, Inc.2014-06-02MNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810351028895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810351028895008103510288958103510288950810351028895

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical body composition analyserAn electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-22 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)623-4997support@fitbit.com

Regulatory Flags#

DUNS number
829454672
Device count
1
Serial number
true

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00898628002045AriaFB201BFB201B2016-10-21
00816137020800Aria 2 Wi-Fi Smart Scale FB202FB202BK2017-10-25
00816137020831Aria 2 Wi-Fi Smart Scale FB202 FB202WT2017-10-25

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