FDA.reportPublic FDA data

Aria 2 Wi-Fi Smart Scale

Primary DI
00816137020831
Brand
Aria 2 Wi-Fi Smart Scale
Company
Fitbit LLC
Model
FB202
Catalog number
FB202WT
Device description
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.
Published
2017-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUHAnalyzer, Body Composition, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUHAnalyzer, Body Composition, ExemptCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816137020831PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816137020831008161370208318161370208310816137020831

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 Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Temperature-13 Degrees Fahrenheit158 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
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00810038852720 Fitbit Irregular Rhythm NotificationsFB604FB6042022-04-25
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00810073612327Body Temperature Sensing SoftwareFB611FB6112025-09-16
00810073612334Loss of Pulse DetectionFB612FB6122025-09-16
00898628002038AriaFB201WFB201W2016-10-21
00898628002045AriaFB201BFB201B2016-10-21
00816137020800Aria 2 Wi-Fi Smart Scale FB202FB202BK2017-10-25
00810351028895AriaFB201B2FB201B22016-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04719846016491CharderCHARDER ELECTRONIC CO., LTD.PUH2026-04-29
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