Tanita Body Composition Analyzer SC-331

No FDA recalls found in the data synced 7 Oct 2026.

Full name

Tanita Body Composition Analyzer, Model Sc-331

510(k) Number

K090479 ↗

FDA Product Code

MNW

Device Class

Class II

Regulation

21 CFR Part 870.2770

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Tanita Corp. of America →

• What types of body composition metrics does the Tanita Body Composition Analyzer SC-331 measure, and how does it work?

  The Tanita Body Composition Analyzer SC-331 measures body fat percentage, muscle mass, water content, and metabolic rate using bioelectrical impedance analysis. It applies a low-level electrical current through the body to estimate these metrics non-invasively, making it suitable for both clinical and home use.

• Is the Tanita Body Composition Analyzer SC-331 a single-use or reusable device, and what are its storage requirements?

  The SC-331 is a reusable electronic instrument, meaning it is designed for repeated use rather than disposal after a single session. It does not require special storage conditions, such as refrigeration or controlled humidity, making it convenient for both clinical and home environments.

• What regulatory pathways has the Tanita Body Composition Analyzer SC-331 followed, and what classification does it hold?

  The SC-331 has undergone FDA 510(k) clearance and complies with the Medical Device Directive (MDD). It is classified as a Class II medical device under regulation number 870.2770, indicating it has undergone substantial equivalence review by the FDA’s Cardiovascular advisory committee.

• How would I determine if the SC-331 is compatible with my practice’s needs, given its regulatory and functional details?

  The SC-331 is intended for non-invasive body composition assessment in both clinical and home settings, making it versatile for healthcare providers, fitness professionals, or individual users. Its reusable design and lack of special storage requirements simplify integration into existing workflows, while its FDA 510(k) clearance and MDD compliance ensure it meets regulatory standards for safety and performance.