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TeleSense

by ScottCare Corporation

510(k) K142180

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 NumberK142180 Date12 Dec 2014ClearedStatusActive

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  • Withdrawn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
DSI
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 TeleSense is a Detector And Alarm, Arrhythmia device intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. It continuously monitors and records data, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with such events.

The device is supplied by ScottCare Corporation and has received FDA 510(k) clearance under K142180. It is classified as a Class II medical device under regulation number 870.1025 and product code DSI, with cardiovascular specialty designation. The device is used in clinical settings for cardiac monitoring and is not described as sterile, single-use, reusable, or MRI-safe in the provided data.

Other devices from ScottCare Corporation

Questions

AI-generated answers, 22 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 TeleSense device used for?

    The TeleSense is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. It continuously monitors and records cardiac data, automatically detecting and recording events via an arrhythmia detection algorithm or manual patient activation, then transmits the recorded event activity for clinical review.

  • How is the TeleSense device supplied and what is its regulatory status?

    The TeleSense device is supplied by ScottCare Corporation and has received FDA 510(k) clearance under K142180. It is classified as a Class II medical device under regulation number 870.1025 with product code DSI and cardiovascular specialty designation, indicating it was found substantially equivalent to a predicate device through a traditional 510(k) submission.

  • Is the TeleSense device sterile, single-use, reusable, or MRI-safe?

    The provided data does not describe the TeleSense device as sterile, single-use, reusable, or MRI-safe. These characteristics are not specified in the device description, specifications, or authorization details, so no claims can be made about its sterility, reusability, or MRI compatibility based on the available information.