Huibao Body Fat Scale

FDA 510(k) K111404 · Zhongshan Huibao Weighing Apparatus Co., Ltd.

Substantially Equivalent

510(k) numberK111404

Submission

Device name
Huibao Body Fat Scale
Applicant
Zhongshan Huibao Weighing Apparatus Co., Ltd.
Zhongshan City, Guangdong, CN
Received
May 19, 2011
Decision date
October 7, 2011
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

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K131394Transtek Glass Body Fat AnalyzerMNW · Special Guangdong Transtek Medical Electronics Co., Ltd.09/18/2013SE
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Questions and answers

When was Huibao Body Fat Scale cleared by the FDA?

Huibao Body Fat Scale (K111404) received a 510(k) decision of Substantially Equivalent on October 7, 2011, 141 days after the submission was received.

What is the product code of K111404?

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