Heart Sync Pediatric Physio AED Pad
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K120536 FDA 510(k)
- FDA Product Code
- MKJ FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5310 FDA 510(k)
- Regulation Number
- 870.5310 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Heart Sync Pediatric Physio AED Pad is an Automated External Defibrillator (Non-Wearable) designed for pediatric use. It is a disposable electrode pad intended to deliver defibrillation shocks to restore normal heart rhythm in children experiencing sudden cardiac arrest.
This device is supplied as a single-use, non-reusable component paired with a compatible defibrillator unit. It is intended for use in emergency cardiac resuscitation settings, adhering to FDA 510(k) clearance under the classification of Class III medical devices (regulation number 870.5310). The pads are sterile and packaged individually for immediate clinical application, with no specific MRI safety considerations noted.
Frequently asked questions
What is the Heart Sync Pediatric Physio AED Pad designed for, and how does it differ from adult AED pads?
The Heart Sync Pediatric Physio AED Pad is specifically designed for pediatric use to deliver defibrillation shocks to children experiencing sudden cardiac arrest. Unlike adult AED pads, it is engineered for smaller pediatric patients, ensuring appropriate energy delivery for their unique physiology. It is a disposable, single-use electrode pad meant to be paired exclusively with a compatible defibrillator unit, adhering to FDA 510(k) clearance for Class III medical devices.
Are the Heart Sync Pediatric Physio AED Pads reusable, and if not, how should they be handled after use?
No, the Heart Sync Pediatric Physio AED Pads are explicitly designed as single-use, non-reusable components. After use, they should be disposed of according to standard biohazard waste protocols to ensure safety and prevent contamination. The sterile packaging ensures immediate clinical readiness, so they are not meant for reuse or reprocessing.
What storage conditions should be followed for the Heart Sync Pediatric Physio AED Pads?
The pads are individually packaged and sterile, so they should be stored in a clean, dry environment protected from extreme temperatures, moisture, and direct sunlight. The packaging integrity must remain intact until use to maintain sterility. Always check the expiration date on the packaging before use.
Can these pediatric AED pads be used with any defibrillator, or do they require a specific compatible unit?
The Heart Sync Pediatric Physio AED Pads are designed to be used exclusively with a compatible defibrillator unit from Heart Sync Inc. They are not interchangeable with other brands or models, as compatibility ensures proper functionality and safety for pediatric defibrillation. Always verify compatibility with the manufacturer’s guidelines.
Are there any special considerations for using these pads in environments with MRI equipment?
The Heart Sync Pediatric Physio AED Pads do not have any specific MRI safety considerations noted in their documentation. However, standard precautions should still be followed when using defibrillation equipment near MRI machines, as metal components or conductive materials could pose risks in magnetic fields. Always consult the defibrillator manufacturer’s guidelines for MRI compatibility.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120536 | Class III | Active |
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Manufacturer
- Manufacturer
- Heart Sync Inc
- FDA Applicant
- Heart Sync, Inc.
Sources (1)
- FDA 510(k) K120536 24 fields · synced Sep 18, 2026