InBody 230 Body Composition Analyzer
510(k) K062603
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK062603 | Date15 Feb 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Other devices from Biospace Inc.
Questions
AI-generated answers, 1 Oct 2026
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.