HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads
by Graphic Controls D.B.A. Vermed
PMA P200007
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP200007 | Date23 Jun 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Automated external defibrillators (non-wearable)
- PMA Number
- FDA Product Code
- MKJ
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.5310
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads are Automated External Defibrillators (Non-Wearable) designed for use with external defibrillators. These pads are intended to monitor and deliver defibrillation energy to patients in cardiopulmonary arrest, including those who are unconscious, not breathing spontaneously, and without a pulse. They are engineered for compatibility with multiple defibrillator models and provide both manual and automated defibrillation capabilities, including cardioversion and pacing when used with manual defibrillators.
These pads are single-use, disposable devices intended for short-term use (less than 8 hours for AEDs and less than 24 hours for manual defibrillators). They are approved for patients over 8 years of age or weighing more than 55 pounds (AED) and for patients weighing over 10 kg (22 pounds) when used with manual defibrillators. Supplied sterile and packaged for one-time use, they are regulated under FDA_PMA (P200007) and comply with regulation number 870.5310. The device is classified as Class III and intended for use in emergency cardiovascular settings.
Questions
AI-generated answers, 18 Sep 2026
What types of defibrillators are these pads compatible with, and how do I know if my device is supported?
The HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads are designed for use with multiple external defibrillator models, including Physio Control’s LifePak-15, LifePak-20/20e, LifePak-1000, Zoll Medical’s R-Series and X-Series, and Cardiac Science’s PowerHeart AED G3 Plus and G3 Pro. The manufacturer explicitly lists these compatible models, so you can verify compatibility by cross-referencing your device’s brand and model against this list. If your defibrillator isn’t listed, these pads may not function as intended.
Are these pads suitable for pediatric patients, and if so, what are the weight and age requirements?
These pads are approved for pediatric patients over 8 years old or weighing more than 55 pounds (25 kg) when used with an Automated External Defibrillator (AED). For manual defibrillators, the requirement is slightly lower: patients must weigh over 10 kg (22 pounds). The manufacturer emphasizes that you should not delay therapy if you’re unsure about exact age or weight, as prompt treatment is critical in cardiac arrest situations.
How long can these pads be used before they need to be replaced, and what happens if they’re used beyond the recommended time?
The HeartSync pads are single-use, disposable devices with a strict usage limit: less than 8 hours when used with an AED, and less than 24 hours when used with a manual defibrillator. Exceeding these time limits may compromise sterility, electrode adhesion, or electrical performance, potentially reducing effectiveness or posing safety risks. They are also sterile upon packaging, so reuse is not recommended.
Do these pads work for both defibrillation and other cardiac functions like pacing or cardioversion?
Yes, these pads are engineered for both defibrillation and additional cardiac functions when used with manual defibrillators. While they are primarily designed for defibrillation in cardiac arrest (unconscious, not breathing, no pulse), they can also support monitoring, pacing, and cardioversion—functions that require precise electrode placement and energy delivery. However, their AED-specific pads are limited to defibrillation and monitoring only.
How should these pads be stored, and what precautions should be taken before use?
The pads are sterile and packaged for single-use, so they should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Before use, ensure the packaging is intact and not expired. If the seal is broken or the pads appear damaged, they should not be used. Always follow manufacturer instructions for proper application to ensure optimal performance and patient safety.