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InnerScan Body Composition Monitor, InnerScan Segmental Body Composition Monitor

by Tanita Corporation of America

510(k) K062652

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK062652 Date28 Dec 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
MNW
Device Class
Class II
Regulation
21 CFR Part 870.2770
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The InnerScan Body Composition Monitor is a device designed to measure body composition, including fat and muscle distribution, using segmental bioelectric impedance analysis (BIA). It provides detailed insights into how body composition varies across different segments of the body, such as the arms, legs, and torso.

The device is supplied as a single-use, non-sterile product and is not MRI safe. It is intended for home use and requires proper storage in a dry environment. The device is authorized for use in the United States under FDA 510(k) clearance (K062652).

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