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ActTrust

by Condor Instruments Ltda. - Epp

510(k) K151784

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 NumberK151784 Date25 May 2016ClearedStatusActive

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  • Withdrawn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
LEL
Device Class
Class II
Regulation
21 CFR Part 882.5050
Advisory Committee
Neurology
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.

ActTrust is a Neurology device classified as Class 2 under FDA regulation number 882.5050 with product code LEL. It is a device intended for sleep assessment as indicated in the device name and specifications.

ActTrust received FDA 510(k) clearance (K151784) through the Traditional pathway on May 25, 2016, after a 329-day review. It is manufactured by Condor Instruments Ltda. - Epp located in Sao Paulo, Brazil.

Questions

AI-generated answers, 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.

  • What is the ActTrust device used for?

    The ActTrust device is intended for sleep assessment, as indicated in its device name and specifications, and is classified as a neurology device under FDA regulation 882.5050 with product code LEL.

  • How was the ActTrust device cleared for market release?

    ActTrust received FDA 510(k) clearance through the Traditional pathway on May 25, 2016, after a 329-day review, under submission number K151784, based on a determination of substantial equivalence.

  • Who manufactures the ActTrust device and where is it located?

    The ActTrust device is manufactured by Condor Instruments Ltda. - Epp, located at Avenida Brigadeiro Luis Antonio, 551, Cj 124, Sao Paulo, Brazil, with postal code 01318-000.