Identifiers
- 510(k) Number
- K052316 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 ECD is an Automated External Defibrillator (Non-Wearable), designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It combines automated voice prompts, real-time rhythm analysis, and biphasic waveform technology to assess and treat ventricular fibrillation or pulseless ventricular tachycardia.
This device is intended for use in pre-hospital, emergency medical, and public-access settings by trained responders. Supplied as a reusable medical device, it requires proper training for operation and periodic maintenance to ensure functionality. The Powerheart ECD is classified as a Class III device under FDA regulations and holds a 510(k) clearance (K052316) for substantial equivalence. Storage and handling must comply with manufacturer guidelines to maintain performance and sterility where applicable.
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 | K052316 | Class III | Active |
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Manufacturer
- Manufacturer
- Cardiac Science Corporation
- FDA Applicant
- Cardiac Science, Inc.
Sources (1)
- FDA 510(k) K052316 24 fields · synced Sep 18, 2026