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SmartShape Body Composition Analyzer Model 4010

by Clio Designs, Inc.

510(k) K023817

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 NumberK023817 Date25 Jun 2003ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

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

The SmartShape Body Composition Analyzer Model 4010 is a Body Composition Analyzer (OpenFDA classification) that employs bioimpedance technology to estimate percent body fat by measuring the transmission speed of low-level electrical current through the body. It analyzes impedance data combined with user inputs—such as weight, gender, age, and height—to derive body composition metrics.

This handheld, programmable device is intended for clinical and research use in settings such as cardiovascular assessment. Supplied as a non-sterile, reusable instrument, it operates under FDA 510(k) clearance (K023817) and adheres to regulation 870.2770. No third-party certification or MRI safety labeling is specified in the available data.