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HBF-1000 Body Composition Analyzer

by Omron Healthcare, Inc.

510(k) K963575

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

Source FDA 510(k), synced 5 Oct 2026.

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963575 Date13 Jun 1997ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Hbf-1000 Omron Body Composition Analyzer
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 HBF-1000 Body Composition Analyzer is a medical device classified as a body composition analyzer. It measures and estimates body fat percentage, muscle mass, and other related metrics using bioelectrical impedance analysis (BIA). This device provides quantitative assessments of body composition, supporting clinical and wellness evaluations.

The HBF-1000 is intended for use in clinical and home settings, requiring no special sterility as it is a non-invasive, reusable device. It operates under FDA 510(k) clearance (K963575) and falls under product code MNW, regulated under 21 CFR 870.2770. The device is designed for single-user operation and does not require MRI safety classification. Storage and maintenance instructions are provided by the manufacturer.

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