510(k) Report

FDA applicant

Scottcare Corporation

Cleveland, OH7 decisions1990–20252 recalls

FDA records 7 decisions for Scottcare Corporation (Cleveland, OH) from 1990 to 2025: 7 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and DRG (Transmitters And Receivers, Physiological…). Its devices cite 7 predicates, 2 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “The ScottCare Corporation”, “Scottcare Corp.”, “Scottcare”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Scottcare Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2008: 12009: 12010: 12014: 12025: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2012: 12016: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Scottcare Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DSIDetector And Alarm, Arrhythmia2decisions
  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency2decisions
  • MWJElectrocardiograph, Ambulatory (Without Analysis)1decision
  • DRNDevice, Counter-Pulsating, External1decision
  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K092947Telesentry, Model TS01Scottcare Corporation · 20103cite it
  • K895719Telerehab System for Cardiac RehabilitationScottcare Corp. · 19901cites it
  • K050778Telerehad 2004Scottcare · 20051cites it

What has FDA decided for it lately?

  • K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation · 2025
  • K142180TelesenseScottcare Corporation · 2014
  • K092947Telesentry, Model TS01Scottcare Corporation · 20102 recalls
  • K083382Chroma, Model: RZ153CScottcare Corporation · 2009
  • K081359Genesis EcpScottcare Corporation · 2008
  • K050778Telerehad 2004Scottcare · 2005
  • K895719Telerehab System for Cardiac RehabilitationScottcare Corp. · 1990

All 4 as Scottcare Corporation →The one decision as The ScottCare Corporation →The one decision as Scottcare Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K092947TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high…Feb 25, 2016Class II
  • K092947TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01. Dist. By: ScottCare…Jan 19, 2012