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Estimation of Body Fat.

Body Composition Meter HBF-1000

The provided text is a 510(k) clearance letter from the FDA for the Omron Healthcare, Inc. HBF-1000 Body Composition Analyzer. It indicates that the device has been found substantially equivalent to a predicate device for the estimation of body fat. However, this document does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, ground truth, or study methodology.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976... You may, therefore, market the device, subject to the general controls provisions of the Act."

This type of FDA letter confirms clearance based on the information provided in the 510(k) submission, but the submission itself, which would contain the study details, is not part of this document.

Therefore, I cannot provide the requested information based solely on the text you've provided. To answer your questions, I would need access to the full 510(k) submission for the Omron HBF-1000, which would include the study report.

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