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Figuretrim

by Colne Medical Co., Ltd.

510(k) K802269

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK802269 Date13 Oct 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
IPF
FDA applicant
Colne Medical Co. , Ltd.
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Figuretrim is a device substantially equivalent to existing products, classified under the product code IPF. It is designed for physical medicine applications.

The Figuretrim is supplied by Colne Medical Co., Ltd. and has received FDA 510(k) clearance, indicated by the k number K802269. The device is intended for use in muscle exercise and features a compact, portable design.

Questions

AI-generated answers, 28 Sep 2026

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

  • What is the Figuretrim used for?

    The Figuretrim is intended for use in muscle exercise, providing a means for physical medicine applications.

  • Is the Figuretrim a single-use device?

    The device data does not specify whether the Figuretrim is single-use or reusable, but its compact design suggests potential for repeated use.

  • What regulatory clearance has the Figuretrim received?

    The Figuretrim has received FDA 510(k) clearance, indicated by the k number K802269, classifying it as substantially equivalent to existing products.