Body Fat Analyzer Model TBF-105

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K930599 ↗

FDA Product Code

DSB

Device Class

Class II

Regulation

21 CFR Part 870.2770

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class II

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  FDA 510(k) K040778 Active Cleared 23 Dec 2004

• Tanita Scale Plus Body Fat Monitor with Body Water Percentage

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• Digital Baby Scale Model Blb-12

  Class I

  FDA 510(k) K932572 Active Cleared 16 Nov 1993

• InnerScan Body Composition Monitor, InnerScan Segmental Body Composition Monitor

  Class II

  FDA 510(k) K062652 Active Cleared 28 Dec 2006

• Tanita Segmental Body Composition Analyzer, Model Bc-418

  Class II

  FDA 510(k) K033157 Active Cleared 8 Apr 2004

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• What is the TBF-105 Body Fat Analyzer used for?

  The TBF-105 is a bioimpedance device designed to assess body composition by measuring body fat percentage, muscle mass, and total body water. It uses electrical impedance to analyze segmental and total body fat distribution, providing quantitative metrics for health and fitness evaluations. This makes it useful for individuals monitoring their physical condition or clinicians tracking patient progress in non-clinical settings.

• Is the TBF-105 Body Fat Analyzer reusable or single-use?

  The TBF-105 is supplied as a reusable instrument. Unlike single-use devices, it requires proper calibration and maintenance as outlined in the manufacturer’s guidelines to ensure accurate and reliable measurements over time. This design allows for repeated use in home or clinical environments.

• Does the TBF-105 Body Fat Analyzer require sterilization?

  No, the TBF-105 does not have sterility requirements as it is intended for non-clinical use in home or clinical settings. Since it is a reusable device, it should be cleaned and maintained according to the manufacturer’s instructions to prevent contamination and ensure proper functionality, but sterilization is not part of its intended use.

• What regulatory approval does the TBF-105 Body Fat Analyzer hold?

  The TBF-105 has received FDA 510(k) clearance (K930599) as substantially equivalent to predicate devices. This clearance confirms it meets regulatory standards for Class II medical devices under FDA regulation 870.2770, specifically for bioimpedance-based body composition analyzers. The approval does not restrict its use to clinical settings only, allowing for both home and clinical applications.

• How should the TBF-105 Body Fat Analyzer be stored?

  While the device specifications do not explicitly detail storage conditions, reusable medical devices like the TBF-105 should generally be stored in a clean, dry environment away from direct sunlight, extreme temperatures, and moisture. Follow the manufacturer’s guidelines for proper storage to maintain accuracy, prevent damage, and extend the device’s lifespan. Avoid storing it in areas prone to dust or contamination.