Scottcare Corporation
Cleveland, OH, US
SCOTTCARE CORPORATION appears in FDA device records in Cleveland, OH. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Scottcare Corporation between 1990 and 2025. The busiest year on record is 1990, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 2005 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2014 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | DRG | Substantially Equivalent | |
| K142180 | TELESENSE | DSI | Substantially Equivalent | |
| K092947 | TELESENTRY, MODEL TS01 | DSI | Substantially Equivalent | |
| K083382 | CHROMA, MODEL: RZ153C | MWJ | Substantially Equivalent | |
| K081359 | GENESIS ECP | DRN | Substantially Equivalent | |
| K050778 | TELEREHAD 2004 | DRG | Substantially Equivalent | |
| K895719 | TELEREHAB SYSTEM FOR CARDIAC REHABILITATION | DXH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1527715 | 1527715 | SCOTTCARE CORPORATION | 4791 WEST 150TH ST., CLEVELAND, OH 44135 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DSKComputer, Blood-Pressure
- DQKComputer, Diagnostic, Programmable
- DSIDetector And Alarm, Arrhythmia
- DRNDevice, Counter-Pulsating, External
- MWJElectrocardiograph, Ambulatory (Without Analysis)
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- DSHRecorder, Magnetic Tape, Medical
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1315-2016 | TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation. Intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. | The firm received a complaint of the battery exploding while recharging. | Class II | Terminated | |
| Z-1400-2012 | TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01. Dist. By: ScottCare Corporation, Cleveland, OH. The TeleSentry device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records the data, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician. | 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. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Scottcare Corporation edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain