Healthphone(Tm)
by Carelink
510(k) K862668
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK862668 | Date22 Dec 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXH
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2920
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Healthphone is a Transmitter and Receiver, Electrocardiograph, Telephone, designed to facilitate remote electrocardiogram (ECG) monitoring. It enables real-time transmission of cardiac signals from a patient to a healthcare provider via telephone lines, allowing for remote assessment of heart rhythm and early detection of cardiac abnormalities. This device integrates with electrocardiograph systems to provide a wireless link for diagnostic purposes in clinical and home settings.
The Healthphone is supplied as a reusable medical device, intended for use in healthcare facilities and telemedicine applications. It operates in non-MRI environments and requires proper calibration and maintenance as specified by the manufacturer. Authorized under FDA 510K clearance (K862668), it adheres to regulatory standards for Class II devices (regulation number 870.2920). Multiple model and reference codes (e.g., 3013689228, 3011265784) identify variations in the device’s configuration for compatibility with different ECG systems.
Other devices from Carelink
Questions
AI-generated answers, 1 Oct 2026
What is the Healthphone used for?
The Healthphone is designed to facilitate remote electrocardiogram (ECG) monitoring by transmitting cardiac signals in real-time over telephone lines. This allows healthcare providers to assess heart rhythm and detect cardiac abnormalities without requiring an in-person visit, making it ideal for both clinical and home telemedicine applications.
Is the Healthphone a single-use or reusable device?
The Healthphone is a reusable medical device intended for use in healthcare facilities and telemedicine programs. As a reusable device, it requires proper calibration, maintenance, and cleaning as specified by the manufacturer to ensure accurate and reliable performance over repeated use.
What model or reference codes should I look for when ordering?
The Healthphone comes in multiple configurations, each identified by specific model or reference codes such as 3013689228, 3011265784, or others listed in the device’s specifications. These codes ensure compatibility with different ECG systems, so verifying the correct code for your intended use is essential before purchasing.
Can the Healthphone be used in an MRI environment?
No, the Healthphone is explicitly designed for use in non-MRI environments. Its components and functionality are not compatible with magnetic resonance imaging settings, so it should only be used in areas where MRI procedures are not conducted.
How is the Healthphone authorized for use?
The Healthphone is authorized under FDA 510K clearance (K862668) and classified as a Class II medical device under regulation number 870.2920. This clearance confirms that the device meets regulatory standards for safety and effectiveness as determined by the FDA’s review process.