Telerehab System for Cardiac Rehabilitation
FDA 510(k) K895719 · Scottcare Corp.
510(k) numberK895719
Submission
- Device name
- Telerehab System for Cardiac Rehabilitation
- Applicant
- Scottcare Corp.
North Attleboro, MA, US - Received
- September 25, 1989
- Decision date
- March 6, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
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More from AliveCor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250259 | TeleRehab Aermos Cardiopulmonary RehabilitationDRG · Traditional | 06/04/2025SE |
| K142180 | TelesenseDSI · Traditional | 12/12/2014SE |
| K092947 | Telesentry, Model TS01DSI · Traditional | 02/26/2010SE |
| K083382 | Chroma, Model: RZ153CMWJ · Traditional | 08/13/2009SE |
| K081359 | Genesis EcpDRN · Special | 05/29/2008SE |
| K050778 | Telerehad 2004DRG · Traditional | 04/13/2005SE |
Questions and answers
When was Telerehab System for Cardiac Rehabilitation cleared by the FDA?
Telerehab System for Cardiac Rehabilitation (K895719) received a 510(k) decision of Substantially Equivalent on March 6, 1990, 162 days after the submission was received.
What is the product code of K895719?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.