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Enertron Cpr Jack

by Enertron Engineering Co.

510(k) K024215

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK024215 Date14 May 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRM
Device Class
Class II
Regulation
21 CFR Part 870.5200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Enertron Cpr Jack is a portable, manually-powered external cardiac compressor used for cardiopulmonary resuscitation. It features a frame structure and a compression mechanism that utilizes a handle and connecting bar to drive a plunger in a perpendicular motion. The device includes a depth-controlling scale that allows for the presetting of compression depth between 1.5 inches and 2.0 inches.

This device is identified under FDA regulation number 870.5200 and holds FDA 510(k) clearance under number K024215. It is classified as a Class 2 medical device within the cardiovascular specialty. The product is manufactured by Enertron Engineering Co. and is intended for use as a manual compression tool.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Enertron CPR Jack?

    The Enertron CPR Jack is a portable, manually-powered external cardiac compressor designed to assist in cardiopulmonary resuscitation. It utilizes a frame structure, handle, and connecting bar to drive a plunger in a perpendicular motion to perform chest compressions.

  • Can the compression depth be adjusted on this device?

    Yes, the device includes a built-in depth-controlling scale. This feature allows the user to preset the compression depth to a specific measurement between 1.5 inches and 2.0 inches to meet clinical requirements.

  • What is the regulatory status of the Enertron CPR Jack?

    The Enertron CPR Jack is a Class 2 medical device classified under FDA regulation number 870.5200. It has received FDA 510(k) clearance under number K024215, confirming it is substantially equivalent to other devices in the cardiovascular specialty.