Skip to content

Huibao Body Fat Scale

by Zhongshan Huibao Weighing Apparatus Co., Ltd.

510(k) K111404

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111404 Date7 Oct 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MNW
Device Class
Class II
Regulation
21 CFR Part 870.2770
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Huibao Body Fat Scale is a Class II medical device classified as an Analyzer, Body Composition. It measures and analyzes body composition metrics, including body fat percentage, muscle mass, and hydration levels, providing quantitative assessments for health monitoring.

This device is intended for single-use or reusable applications in home or clinical settings, depending on the model. It is not sterile and requires proper storage as specified in the manufacturer’s instructions. The device is FDA-cleared under the 510(k) pathway with a clearance type designated as Traditional, and it falls under the product code MNW. Multiple registration numbers and FEI numbers are associated with its regulatory compliance.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What metrics does the Huibao Body Fat Scale measure?

    The Huibao Body Fat Scale quantifies body composition metrics, including body fat percentage, muscle mass, and hydration levels. These measurements help users assess overall health and monitor physiological changes over time, making it useful for both personal health tracking and clinical evaluations.

  • Is the Huibao Body Fat Scale intended for single-use or reusable applications?

    The Huibao Body Fat Scale can be used in either single-use or reusable settings, depending on the specific model. The manufacturer provides guidelines for cleaning and maintenance to ensure proper reuse. Always follow the included instructions to maintain accuracy and hygiene.

  • Is the Huibao Body Fat Scale sterile?

    No, the Huibao Body Fat Scale is not sterile. It is designed for non-invasive use and does not require sterilization. Proper storage and handling, as outlined in the manufacturer’s instructions, are essential to prevent contamination and ensure reliable performance.

  • What regulatory pathway does the Huibao Body Fat Scale follow?

    The Huibao Body Fat Scale is FDA-cleared under the 510(k) pathway, specifically through a Traditional clearance process. It falls under product code MNW and is classified as a Class II medical device. The device was reviewed by the Cardiovascular Advisory Committee (CV) and is substantively equivalent to a predicate device.

  • How should the Huibao Body Fat Scale be stored?

    The Huibao Body Fat Scale should be stored according to the manufacturer’s instructions to preserve its functionality and accuracy. This typically includes keeping it in a dry, clean environment away from direct sunlight or extreme temperatures. Proper storage also helps maintain the device’s calibration and ensures longevity for both single-use and reusable models.