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InBody 230 Body Composition Analyzer

by Biospace Inc.

510(k) K062603

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 NumberK062603 Date15 Feb 2007ClearedStatusActive

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  • Withdrawn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)

Full name
Biospace Body Composition Analyzers, Model Inbody 230
510(k) Number
FDA Product Code
MNW
FDA applicant
Biospace Corporation Limited
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 InBody 230 is a body composition analyzer designed to measure and assess body segmental composition. It employs bioelectrical impedance analysis to provide detailed metrics on muscle mass, fat distribution, and hydration levels across different body segments, supporting clinical and fitness evaluations.

This device is intended for use in clinical, research, and fitness settings and is supplied as a reusable medical instrument. It has received FDA 510(k) clearance under the Cardiovascular advisory committee and is classified as a Class II device (regulation number 870.2770). The analyzer requires proper calibration and maintenance in accordance with manufacturer guidelines to ensure accurate and reliable results.

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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 is the InBody 230 used for?

    The InBody 230 is a body composition analyzer designed to assess detailed metrics such as muscle mass, fat distribution, and hydration levels across different body segments. It employs bioelectrical impedance analysis (BIA) to provide precise measurements, making it useful in clinical settings for patient evaluations, research studies for body composition analysis, and fitness assessments to track progress and optimize training programs.

  • Is the InBody 230 a reusable or single-use device?

    The InBody 230 is supplied as a reusable medical instrument. Since it is intended for repeated use across clinical, research, and fitness settings, proper calibration and maintenance are required to ensure accuracy and reliability over time. The manufacturer provides guidelines for cleaning and upkeep to extend its operational lifespan.

  • How does the InBody 230 differ from other body composition analyzers?

    The InBody 230 stands out due to its ability to measure body composition by segment—providing detailed insights into muscle mass, fat distribution, and hydration levels in specific body areas (e.g., arms, legs, torso). This segmental analysis offers a more granular understanding compared to whole-body analyzers, making it particularly valuable for clinical assessments, personalized fitness programs, and research applications where precision matters.

  • What maintenance is required to keep the InBody 230 accurate?

    To ensure the InBody 230 delivers reliable results, it must be calibrated and maintained according to the manufacturer’s guidelines. This includes regular cleaning of electrodes and the device’s surface to prevent buildup of substances that could interfere with measurements. Periodic recalibration may also be necessary to account for wear or environmental factors, as specified in the device’s operational manual.

  • Where can the InBody 230 be used, and what settings is it approved for?

    The InBody 230 is approved for use in clinical, research, and fitness settings. Its FDA 510(k) clearance under the Cardiovascular advisory committee and classification as a Class II device (regulation number 870.2770) indicate its suitability for medical and diagnostic applications, though its primary utility spans broader assessments beyond cardiovascular health alone. Clinicians may use it for patient evaluations, researchers for body composition studies, and fitness professionals for client monitoring.