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Fast-Patch

FDA 510(k)

Class II (US FDA 510(k))

510(k) K871224

by Physio-Control Corp.

Identifiers

510(k) Number
K871224 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 Fast-Patch is a Dc-Defibrillator, Low-Energy, including paddles, classified as a Class 2 device. It is a cardiac event recorder used in cardiovascular applications. The device is manufactured by Physio-Control Corp.

The Fast-Patch is supplied as a single-use device and is regulated under the product code LDD. It has been cleared by the FDA under the 510K clearance type, with a decision date of 1987-05-20 and a k number of K871224. The device is stored and distributed by Physio-Control Corp.

Frequently asked questions

What is the Fast-Patch used for?

The Fast-Patch is used in cardiovascular applications as a cardiac event recorder.

Is the Fast-Patch a single-use device?

Yes, the Fast-Patch is supplied as a single-use device, reducing the risk of cross-contamination and ensuring patient safety.

How is the Fast-Patch regulated?

The Fast-Patch is regulated under the product code LDD and has been cleared by the FDA under the 510K clearance type.

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 Fast-Patch(tm) - allmed.wiki, Fast-patch (tm) 510 (k) FDA Premarket Notification K871224 PHYSIO ..., Physio-Control Corp. - FDA 510 (k) Cleared Devices, Physio-Control Corp. — 80 FDA 510 (k)s · DeviceClearance, FAST-PATCH - Shock Value

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) K871224 24 fields · synced Oct 1, 2026