Well@Home System
by Zoe Medical, Inc. 510(k)
Active
510(k) K040012
Overview
The Well@Home System is a patient monitoring device classified under the FDA product code DXN, designed for remote health status assessment. It collects vital signs, symptoms, and medication compliance data through scheduled patient activities, enabling clinical oversight outside traditional healthcare settings. The system supports longitudinal monitoring of patients in home or facility-based environments, facilitating early intervention based on observed trends.
Supplied as a reusable medical device, the Well@Home System operates in both home and healthcare facility settings. It requires no specific sterility classification as it is not invasive or directly applied to sterile fields. The device holds an FDA 510(k) clearance (K040012) under the Traditional pathway, with a decision date of April 2, 2004. No third-party review was involved, and its advisory committee classification is Cardiovascular (CV).
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040012 | Date2 Apr 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-2166-2010
Touch panel may become unresponsive.
Specification
- 510(k) Number
- FDA Product Code
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Zoe Medical, Inc.
Questions
What is the Well@Home System used for?
The Well@Home System is designed for remote health status assessment, collecting vital signs, symptoms, and medication compliance data through scheduled patient activities. This allows clinicians to monitor patients outside traditional healthcare settings—such as homes or facilities—over extended periods, helping detect trends early for timely intervention.
Is the Well@Home System reusable or single-use?
The Well@Home System is supplied as a reusable medical device. It is not intended for invasive use or direct application to sterile fields, so no specific sterility classification applies. Reusability ensures cost-effectiveness and continuous patient monitoring without frequent replacements.
Where can the Well@Home System be used?
The system is approved for use in both home environments and healthcare facility settings. Its remote monitoring capabilities make it ideal for longitudinal patient tracking, whether the patient resides at home or in a clinical or long-term care facility.
Does the Well@Home System require sterilization?
No, the Well@Home System does not require sterilization as it is classified as a non-invasive, non-sterile-field device. Its design ensures safe reuse without direct contact with sterile areas or bodily openings, eliminating the need for sterilization procedures.
What regulatory pathway was followed for the Well@Home System?
The Well@Home System received FDA clearance through the Traditional 510(k) pathway (K040012) and was deemed substantially equivalent to a predicate device. The decision was made by the FDA’s Cardiovascular (CV) advisory committee on April 2, 2004, with no third-party review involved.