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Clue Medical and Clue Medical Basic

by Telovital GmbH Telemedizin 2 variants

510(k) K082013

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 NumberK082013 Date10 Nov 2008ClearedStatusActive

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  • Withdrawn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
DPS
Device Class
Class II
Regulation
21 CFR Part 870.2340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Clue Medical and Clue Medical Basic are telephone-based electrocardiogram (ECG) recording devices (per 21 CFR 870.2920), designed to capture and store ECG data from patients. These devices enable remote transmission of recorded ECG signals for subsequent review by healthcare professionals, facilitating diagnostic assessment.

Supplied as a reusable system, the devices require no sterility assurance and are intended for use in home or outpatient settings. They feature wireless data transmission for ECG recordings, with the Clue Medical Basic incorporating an enhanced transmission method. Authorized under FDA 510(k) clearance (K082013), these devices comply with Class II regulatory standards and are intended for single-patient use per session.

Other devices from Telovital GmbH Telemedizin