Data / Medical devices / United States / Scottcare Corporation
Scottcare Corporation: FDA-registered device maker in Cleveland, OH, United States, 11 510(k) clearances
Scottcare Corporation is registered with the FDA (registration 1527715) in Cleveland, OH, United States. It lists 9 device types. The FDA files 11 510(k) clearances under its listings, the newest dated June 4, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1527715
- Address
- 4791 West 150TH ST., Cleveland, OH, United States, 44135
- Owner or operator
- ScottCare Corporation (9915036)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- February 1, 2006
- Registered through
- 2026
- Brand names listed
- 151, 153+, ABP For Windows, ABPCare, Advantage, Aermos, Arrio, Chroma and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Blood-Pressure | DSK | 2 | Manufacturer | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Detector And Alarm, Arrhythmia | DSI | 2 | Manufacturer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer | accessdata.fda.gov |
| Recorder, Magnetic Tape, Medical | DSH | 2 | Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 4, 2025 | K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | DRG | Substantially Equivalent | The ScottCare Corporation | accessdata.fda.gov |
| December 12, 2014 | K142180 | TELESENSE | DSI | Substantially Equivalent | Scottcare Corporation | accessdata.fda.gov |
| February 26, 2010 | K092947 | TELESENTRY, MODEL TS01 | DSI | Substantially Equivalent | Scottcare Corporation | accessdata.fda.gov |
| August 13, 2009 | K083382 | CHROMA, MODEL: RZ153C | MWJ | Substantially Equivalent | Scottcare Corporation | accessdata.fda.gov |
| September 15, 2006 | K061780 | TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + | DXH | Substantially Equivalent | Rozinn Electronics, Inc. | accessdata.fda.gov |
| April 13, 2005 | K050778 | TELEREHAD 2004 | DRG | Substantially Equivalent | Scottcare | accessdata.fda.gov |
| September 22, 2004 | K042463 | HOLTER PLUS | DQK | Substantially Equivalent | Rozinn Electronics, Inc. | accessdata.fda.gov |
| October 24, 2002 | K022540 | CARDIO ID+(RZ153+) | DSH | Substantially Equivalent | Rozinn Electronics, Inc. | accessdata.fda.gov |
| July 24, 2002 | K021517 | ABP FOR WINDOWS | DSK | Substantially Equivalent | Rozinn Electronics, Inc. | accessdata.fda.gov |
| April 5, 2002 | K020213 | NETLINK/NETSCAN | DXH | Substantially Equivalent | Rozinn Electronics, Inc. | accessdata.fda.gov |
| October 22, 1990 | K903331 | ROZINN 151 | DSH | Substantially Equivalent | Rozinn Electronics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 25, 2016 | 73381 | Class II | Terminated | 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 diagnosti | The firm received a complaint of the battery exploding while recharging. | accessdata.fda.gov |
| January 19, 2012 | 61370 | Not yet classified | Terminated | 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 | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Detector And Alarm, Arrhythmia
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Recorder, Magnetic Tape, Medical
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
Updated June 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.