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Body Analysis System (Deemed SE 87/09/18)

by Medi-Sport Testing, Inc.

510(k) K851415

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK851415 Date8 Jul 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
DSB
Device Class
Class II
Regulation
21 CFR Part 870.2770
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Body Analysis System is an impedance plethysmograph, a device used to measure body composition by assessing electrical impedance through tissues. It quantifies parameters such as fat mass, lean body mass, and total body water by analyzing resistance and reactance at multiple frequencies.

This system is intended for use in clinical and research settings, supplied as a reusable medical device under 21 CFR 870.2770. It operates in non-MRI environments and requires proper calibration and maintenance. Authorized for commercial distribution in the United States via FDA 510(k) clearance (K851415), it is classified as a Class II device under the FDA’s regulatory framework.

Questions

AI-generated answers, 19 Sep 2026

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

  • What clinical applications is the Body Analysis System primarily designed for, and how does it work?

    The Body Analysis System is an impedance plethysmograph used to measure body composition in clinical and research settings. It quantifies parameters like fat mass, lean body mass, and total body water by analyzing electrical resistance and reactance at multiple frequencies. This non-invasive method helps assess body composition without requiring MRI or other imaging environments.

  • Is the Body Analysis System single-use or reusable, and what maintenance does it require?

    The Body Analysis System is a reusable medical device, as indicated by its classification under 21 CFR 870.2770. Proper calibration and maintenance are required to ensure accurate measurements, as the device relies on precise electrical impedance analysis.

  • What regulatory pathway was followed for FDA clearance, and where is it distributed commercially?

    The Body Analysis System received FDA 510(k) clearance (K851415) through a traditional review process, classified as substantially equivalent under the FDA’s regulatory framework. It is authorized for commercial distribution in the United States and is categorized as a Class II device.

  • Can this device be used in environments where MRI equipment is present, and what are its key specifications?

    No, the Body Analysis System is explicitly designed for use in non-MRI environments. While the provided data does not list specific technical specifications (e.g., frequency ranges, measurement accuracy), it confirms the device operates as an impedance plethysmograph, measuring resistance and reactance across multiple frequencies to derive body composition metrics.