Aria Wifi Smart Scale

FDA 510(k) K133872 · Fitbit, Inc.

Substantially Equivalent

510(k) numberK133872

Submission

Device name
Aria Wifi Smart Scale
Applicant
Fitbit, Inc.
Fairfax, VA, US
Received
December 20, 2013
Decision date
June 2, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNW – Analyzer, Body Composition
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2770
Specialty
Cardiovascular

Other 510(k)s with product code MNW

510(k)DeviceApplicantDecision
K231116Multi-parameter detectorMNW · Traditional Zhongshan Jinli Electronic Weighing Equipment…06/15/2024SE
K140045Body Composition AnalyzerMNW · Traditional Jawon Medical Co., Ltd.02/18/2015SE
K141483Biospace Body Composition AnalyzerMNW · Traditional Biospace Corporation Limited09/23/2014SE
K140594Body Fat Analyzer and ScaleMNW · Traditional Conmo Electronic Company Limited05/30/2014SE
K130856Bia / Vitality AnalyzerMNW · Traditional Ipgdx, LLC11/25/2013SE
K130777InbodyMNW · Traditional Biospace Corporation Limited11/25/2013SE
K130952Precision One Lifecare; Detecto; DetectoMNW · Traditional Precision One Lifecare, Ltd.09/26/2013SE
K131394Transtek Glass Body Fat AnalyzerMNW · Special Guangdong Transtek Medical Electronics Co., Ltd.09/18/2013SE
K130311Transtek Body Fat AnalyzerMNW · Traditional Guangdong Transtek Medical Electronics Co., Ltd.05/30/2013SE
K122388Seca Medical Body Compostion Analyzer 514, Seca Mbca 514, Seca Mbca, Seca 514MNW · Traditional Seca GmbH & Co. KG05/02/2013SE

More from Seca GmbH & Co. KG

510(k)DeviceDecision
K242967Loss of Pulse DetectionSDY · Traditional 02/25/2025SE
K243778Body Temperature Software (BTS)QZA · Special 02/13/2025SE
K212372Fitbit Irregular Rhythm NotificationsQDB · Traditional 04/08/2022SE
K200948Fitbit ECG AppQDA · Traditional 09/11/2020SE

Questions and answers

When was Aria Wifi Smart Scale cleared by the FDA?

Aria Wifi Smart Scale (K133872) received a 510(k) decision of Substantially Equivalent on June 2, 2014, 164 days after the submission was received.

What is the product code of K133872?

The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.