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Telesentry Model TS01

by ScottCare Corporation

510(k) K092947

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK092947 Date26 Feb 2010ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1315-2016 FDA Class II initiated 25 Feb 2016

    The firm received a complaint of the battery exploding while recharging.

    • Terminated Z-1400-2012 FDA Not yet classified initiated 19 Jan 2012

    Certain TeleSentry Devices contain a Bad SD Card. When the SD Card goes bad, the TeleSentry Device cannot read or write data to the SD Card. The TeleSentry Device then stops functioning.

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  • Withdrawn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, 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.

The Telesentry Model TS01 is a Detector and Alarm, Arrhythmia device, classified under FDA regulation 870.1025. It is designed to detect and alert for arrhythmias, providing real-time monitoring and audible or visual signals to indicate cardiac irregularities. This device is intended for use in clinical settings where continuous cardiac rhythm assessment is required, such as intensive care units or cardiac monitoring stations.

The Telesentry Model TS01 is supplied as a reusable device and is intended for use in hospital or clinical environments. It operates within the constraints of FDA 510(k) clearance (K092947) under the Cardiovascular advisory committee, with a classification as a Class II device. No specific MRI safety information is provided, and the device is not intended for single-use. Storage and handling instructions are not detailed in the available data, but it is regulated under the Detector and Alarm, Arrhythmia product code (DSI)

Other devices from ScottCare Corporation

  • TeleSense

    Class II

  • Chroma, Model: RZ153C

    Class II

  • Genesis Ecp

    Class II

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 Telesentry Model TS01 used for?

    The Telesentry Model TS01 is designed to detect and alert for arrhythmias, providing real-time monitoring of cardiac rhythm. It is specifically intended for use in clinical settings such as intensive care units or cardiac monitoring stations, where continuous assessment of heart rhythm is critical.

  • Is the Telesentry Model TS01 a single-use or reusable device?

    The Telesentry Model TS01 is a reusable device. It is intended for use in hospital or clinical environments, where it can be utilized repeatedly after proper cleaning and maintenance, as outlined by the manufacturer’s guidelines.

  • What regulatory approval does the Telesentry Model TS01 have?

    The Telesentry Model TS01 holds FDA 510(k) clearance under the classification of Detector and Alarm, Arrhythmia (product code DSI). It was reviewed by the Cardiovascular Advisory Committee and is classified as a Class II device, indicating it has been determined to be substantially equivalent to a legally marketed device.

  • Can the Telesentry Model TS01 be used with MRI equipment?

    The available data does not specify MRI safety information for the Telesentry Model TS01. Clinicians should consult the manufacturer’s instructions and ensure compatibility with their specific MRI systems before use to avoid potential risks.

  • What are the key specifications or features of the Telesentry Model TS01?

    The Telesentry Model TS01 provides audible or visual signals to indicate cardiac irregularities in real-time. It operates under FDA regulation 870.1025 and is intended for continuous cardiac rhythm assessment. The device is not intended for single-use and is primarily designed for use in clinical environments where ongoing monitoring is required.