AccuHeart Electrode Belt
by Advanced Bioelectric Corporation
510(k) K043361
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK043361 | Date22 Mar 2005 | 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- Withdrawn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
- DRX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2360
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The AccuHeart Electrode Belt is a reusable ECG electrode system designed for continuous monitoring of cardiac electrical activity. It consists of an electrode assembly integrated into an elastic chest belt, providing secure positioning against the skin without the need for electrolytic gels or adhesives. The device is intended for use in clinical and ambulatory settings to capture accurate electrocardiographic signals for diagnostic purposes.
This device is supplied as a reusable system, requiring proper cleaning and maintenance between uses. It is classified under the product code DRX and has received FDA 510(k) clearance as substantially equivalent to a predicate device. The belt is intended for use in environments where continuous ECG monitoring is required, such as cardiac care units, telemetry wards, or patient telemetry systems, and must comply with relevant safety and performance standards.
Questions
AI-generated answers, 19 Sep 2026
What types of clinical environments is the AccuHeart Electrode Belt designed for, and how does its reusable design impact its use in these settings?
The AccuHeart Electrode Belt is specifically designed for environments requiring continuous ECG monitoring, such as cardiac care units, telemetry wards, or patient telemetry systems. Its reusable nature means it can be used repeatedly in these settings after proper cleaning and maintenance, reducing the need for frequent replacements and lowering operational costs. This design also eliminates the need for electrolytic gels or adhesives, making it ideal for long-term or frequent patient monitoring where convenience and patient comfort are important.
How does the AccuHeart Electrode Belt ensure secure positioning on the patient without relying on gels or adhesives?
The AccuHeart Electrode Belt integrates an electrode assembly into an elastic chest belt, which provides a snug and secure fit against the skin. The elasticity ensures consistent contact with the patient’s chest, maintaining stable ECG signal capture without the need for additional electrolytic gels or adhesives, which can degrade over time or cause skin irritation.
Is the AccuHeart Electrode Belt intended for single-use or repeated use, and what maintenance is required between patients?
The AccuHeart Electrode Belt is designed for reusable use, meaning it can be used multiple times with proper cleaning and maintenance between patients. Since it is not sterile out-of-the-box, it must be thoroughly cleaned and disinfected according to manufacturer guidelines to ensure hygiene and prevent cross-contamination, making it suitable for clinical settings where reusable monitoring equipment is standard.
What regulatory pathway was followed for the FDA clearance of the AccuHeart Electrode Belt, and what does this mean for its use in healthcare settings?
The AccuHeart Electrode Belt received FDA 510(k) clearance through a traditional review process, determined to be *substantially equivalent* to a predicate device. This means the FDA evaluated it against existing, legally marketed devices in the same category (product code DRX) and confirmed it meets safety and performance standards. Clinically, this clearance indicates the device has undergone rigorous testing to ensure reliability for continuous ECG monitoring in settings like cardiac care units or telemetry wards.