FDA Registration
Active
🇺🇸 United States
SCOTTCARE CORPORATION
Reg #: 1527715
·
FEI: 1527715
·
Expires 2026
Products
9
Proprietary Names
23
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- SCOTTCARE CORPORATION
- Registration Number
- 1527715
- FEI Number
- 1527715
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4791 WEST 150TH ST.
- City
- CLEVELAND
- State
- OH
- ZIP
- 44135
- Country
- US
Regulatory Submissions
- 510(k) Number
- K022540
Owner / Operator
- Firm Name
- ScottCare Corporation
- Operator Number
- 9915036
- Address
- 4791 W150th Street, --
- City
- Cleveland
- State
- OH
- Postal Code
- 44135
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Recorder, Magnetic Tape, Medical | DSH | Class 2 | Cardiovascular | No | 2007-11-27 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2010-12-13 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2010-12-13 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2007-11-27 |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2009-11-23 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2007-11-27 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2007-11-27 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2025-09-18 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2025-09-18 |
Proprietary Names
153+
TeleSentry
Dynavision
Holter Plus
HolterCare
Chroma
Chroma2
EZ Link
NetLink/ NetScan
EventCare
OneView
TTM for Windows+
ABP For Windows
ABPCare
Arrio
TeleSense
SCOTTCARE TELEREHAB 2004 CARDIO
INNOVO
DS2
Advantage
VersaCare
Aermos
151
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only