9131 Defibrillation Electrodes
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K082090 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 9131 Defibrillation Electrodes are adhesive pads designed for use with automated external defibrillators (non-wearable). These electrodes deliver high-energy electrical shocks to the chest during cardiac arrest to restore normal heart rhythm, a critical intervention in sudden cardiac death.
Supplied as single-use, sterile adhesive pads, these electrodes are intended for emergency use in out-of-hospital and pre-hospital settings. They are classified as Class III medical devices under FDA regulations (870.5310) and require FDA clearance (510K K082090). Storage and handling must comply with manufacturer guidelines to ensure functionality and sterility prior to use.
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 | K082090 | Class III | Active |
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Manufacturer
- Manufacturer
- Cardiac Science Corporation
Sources (1)
- FDA 510(k) K082090 24 fields · synced Sep 18, 2026