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BC100 Body Composition Analysis System

by Athletic Iq, Inc. 510(k)

Active United States

510(k) K060552

Overview

The BC100 Body Composition Analysis System is a medical device designed to estimate percent body fat using bioelectrical impedance data. It is classified as a Class II medical device under the U.S. Food and Drug Administration (FDA) and is intended for clinical testing purposes.

The system is supplied as a single-use device and is not reusable. It requires proper storage conditions and is not MRI safe. The device is authorized under FDA 510(k) clearance (K060552) and is intended for use in clinical settings.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK060552 Date24 May 2006ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

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

Questions

  • What is the BC100 Body Composition Analysis System used for?

    The BC100 Body Composition Analysis System is used to estimate percent body fat using bioelectrical impedance data for clinical testing purposes.

  • Is the BC100 Body Composition Analysis System reusable?

    No, the BC100 Body Composition Analysis System is supplied as a single-use device and is not reusable.

  • What are the storage conditions for the BC100 Body Composition Analysis System?

    The BC100 Body Composition Analysis System requires proper storage conditions, but specific details are not provided. It is also noted that the device is not MRI safe.

  • What is the regulatory status of the BC100 Body Composition Analysis System?

    The BC100 Body Composition Analysis System is authorized under FDA 510(k) clearance (K060552).