Identifiers
- 510(k) Number
- K970741 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 Powerheart AECD is an Automated External Defibrillator (Non-Wearable), designed to deliver life-saving electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. This device continuously monitors the patient’s heart rhythm and automatically analyzes the need for defibrillation, providing clear voice prompts to guide rescuers through the resuscitation process.
Supplied as a reusable medical device, the Powerheart AECD is intended for use in pre-hospital, emergency medical, and clinical settings. It is classified as a Class III device under FDA regulations (870.5310) and holds a Traditional 510(k) clearance (K970741) with a Substantially Equivalent determination from the Cardiovascular Advisory Committee. The device requires proper training for operation and must be maintained according to manufacturer guidelines to ensure reliable performance.
Frequently asked questions
Is the Powerheart AECD designed for single-use or can it be reused after maintenance?
The Powerheart AECD is a reusable medical device, meaning it is intended to be used multiple times after proper maintenance and servicing according to the manufacturer’s guidelines. Since it is classified as a reusable device, it must be cleaned, inspected, and calibrated regularly to ensure reliable performance and safety in emergency situations.
What types of settings is the Powerheart AECD approved for use in, and what training is required?
The Powerheart AECD is approved for use in pre-hospital, emergency medical, and clinical settings where sudden cardiac arrest may occur. Because it delivers life-saving electrical shocks and continuously monitors heart rhythms, proper training is mandatory for operators to ensure correct usage, interpretation of prompts, and adherence to resuscitation protocols.
How is the regulatory pathway for the Powerheart AECD structured, and what does the Cardiovascular Advisory Committee’s role entail?
The Powerheart AECD holds a Traditional 510(k) clearance (K970741) with a Substantially Equivalent determination from the FDA’s Cardiovascular Advisory Committee. This means the device was reviewed by the committee to confirm it is comparable to a legally marketed predicate device in terms of technology and safety. The committee’s role was advisory, ensuring the device met regulatory standards before clearance.
Does the Powerheart AECD require any special storage conditions, and how should it be handled between uses?
While the device data does not specify exact storage conditions, as a reusable Class III medical device, the Powerheart AECD should be stored in a clean, dry environment away from extreme temperatures or moisture to prevent damage. Between uses, it must undergo manufacturer-recommended maintenance, including cleaning, calibration, and inspection, to ensure it remains operational for emergency resuscitation scenarios.
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 | K970741 | Class III | Active |
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Manufacturer
- Manufacturer
- Cardiac Science Corporation
- FDA Applicant
- Cardiac Science, Inc.
Sources (1)
- FDA 510(k) K970741 24 fields · synced Oct 6, 2026