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LifePak 9 Monitor/Defibrillator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K902288

by Physio-Control Corp.

Identifiers

510(k) Number
K902288 FDA 510(k)
FDA Product Code
LDD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5300 FDA 510(k)
Regulation Number
870.5300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The LifePak 9 Monitor/Defibrillator is a Class II medical device designed for low-energy defibrillation, including paddle-based applications. It combines defibrillation capabilities with ECG monitoring, offering both 3-lead and 5-lead configurations to assess cardiac rhythms. The device also incorporates non-invasive pacing and cardioscopic features for advanced cardiac assessment during resuscitation efforts.

This device is intended for use in clinical settings, including emergency response and hospital environments, where rapid cardiac intervention is required. Supplied as a reusable medical instrument, it requires proper maintenance and calibration per manufacturer guidelines. The LifePak 9 adheres to FDA 510(k) clearance under the Cardiovascular advisory committee and is regulated under the classification Dc-Defibrillator, Low-Energy (Including Paddles). No sterility or single-use specifications are indicated.

Frequently asked questions

What is the primary use of the modified LifePak 9 Monitor/Defibrillator?

The modified LifePak 9 is a reusable Class II medical device designed for low-energy defibrillation, including paddle-based applications. It is specifically intended for clinical settings like emergency response and hospitals, where quick intervention for cardiac emergencies is required. The device integrates defibrillation with ECG monitoring (3-lead or 5-lead) and advanced features like non-invasive pacing and cardioscopic assessment to aid in resuscitation efforts.

Is the LifePak 9 supplied as a single-use or reusable device?

The modified LifePak 9 is supplied as a reusable medical instrument. Unlike single-use devices, it requires regular maintenance and calibration to ensure accurate performance and safety. The manufacturer provides guidelines for proper upkeep to sustain its functionality over repeated use.

What configurations does the LifePak 9 support for ECG monitoring?

The modified LifePak 9 supports both 3-lead and 5-lead ECG configurations. These configurations allow clinicians to assess cardiac rhythms more comprehensively, which is critical during resuscitation or emergency cardiac interventions. The flexibility in lead options enhances diagnostic capabilities during treatment.

Does the LifePak 9 include any additional features beyond defibrillation?

Yes, the modified LifePak 9 incorporates non-invasive pacing and cardioscopic features. Non-invasive pacing helps stabilize cardiac rhythms without invasive procedures, while cardioscopy provides visual assessment of the heart’s condition during resuscitation. These features expand its utility beyond traditional defibrillation.

How is the regulatory status of this device determined?

The modified LifePak 9 holds FDA 510(k) clearance, classified under the Cardiovascular advisory committee and designated as a low-energy defibrillator (including paddle-based applications). This classification ensures it meets regulatory standards for safety and effectiveness in its intended use. The device is regulated under the product code LDD and falls under the classification Dc-Defibrillator, Low-Energy.

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. Sources consulted: Physio-Control Lifepak 9 Defibrillator Featuring 1-2-3 Operation, PDF Physio Control Lifepak 9 Defibrillator - Soma Tech Intl, Physio-Control - Lifepak 9 Manuals and Documents | Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Physio-Control Corp.

Sources (1)

  • FDA 510(k) K902288 24 fields · synced Oct 1, 2026