Carefone Home Uterine Activity Monitor System, Model 2001
PMA P910063
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP910063 | Date29 Sep 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Carefone(Tm)Home Uterine Activity Monitor System
- Generic Name
- Home uterine activity monitor
- PMA Number
- FDA Product Code
- LQK
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.2730
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
The Carefone Home Uterine Activity Monitor System, Model 2001, is a Class II home uterine activity monitor designed for continuous fetal heart rate and uterine contraction monitoring. It provides real-time data to assess fetal well-being during pregnancy, particularly for high-risk pregnancies or outpatient settings where in-clinic monitoring is impractical.
This system is intended for single-use in home or outpatient environments, supplied sterile and intended for use with disposable sensors and electrodes. It operates under FDA approval (PMA P910063) and adheres to regulatory standards for obstetric monitoring, ensuring compliance with 21 CFR Part 884.2730. Storage and handling follow manufacturer guidelines to maintain sterility and functionality prior to use.
Other devices from Matria Healthcare, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the Carefone Home Uterine Activity Monitor System primarily used for in clinical settings?
The Carefone Home Uterine Activity Monitor System, Model 2001, is designed for continuous monitoring of fetal heart rate and uterine contractions. It is particularly suited for assessing fetal well-being in high-risk pregnancies or outpatient settings where traditional in-clinic monitoring is not feasible. This allows clinicians to track the baby’s health remotely, ensuring timely intervention if needed.
Is the Carefone Home Uterine Activity Monitor System intended for reuse or single-use, and how is it supplied?
The Carefone Home Uterine Activity Monitor System is explicitly intended for single-use in home or outpatient environments. It is supplied sterile, along with disposable sensors and electrodes, ensuring safety and hygiene for each use. This design eliminates the need for reprocessing and reduces the risk of cross-contamination.
What regulatory approval does the Carefone Home Uterine Activity Monitor System hold, and how does it comply with obstetric monitoring standards?
The Carefone Home Uterine Activity Monitor System holds FDA Premarket Approval (PMA P910063), confirming its compliance with regulatory standards for obstetric monitoring. It adheres to 21 CFR Part 884.2730, which governs home uterine activity monitors, ensuring its safety, effectiveness, and suitability for continuous fetal monitoring in approved clinical applications.
How should the Carefone Home Uterine Activity Monitor System be stored to maintain its sterility and functionality before use?
The manufacturer provides specific guidelines for storage and handling to preserve sterility and functionality. While the exact details are not listed here, the system is supplied sterile, so it should be stored in a clean, dry environment—protected from moisture, extreme temperatures, and physical damage—until immediate use. Adhering to these instructions ensures the device remains ready for single-use applications as intended.