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The JUMP START is intended to be used to treat patients in cardiopulmonary arrest. It is intended for use in either in-hospital or out-of-hospital arrests.

It is intended for use by personnel who are authorized by a physician/medical director, and who have the following training and skills:

• American Heart Association Heartsaver course, American Red Cross CPR / AED course, or equivalent
• Training in the use of the MRL JUMP START

It should only be used on patients who are unconscious, pulseless, and not breathing spontaneously. The biphasic waveform employed by the JUMP START has not been clinically tested on pediatric patients The device has not been evaluated for cardioversion of atrial fibrillation or direct (internal) cardiac defibrillation. It should not be used on pediatric patients less than 8 years old.

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This document is a 510(k) clearance letter from the FDA for the "Jump Start" Automated External Defibrillator (AED). It states that the device is substantially equivalent to a legally marketed predicate device.

Unfortunately, this document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Here's why:

• 510(k) Clearance: A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a comprehensive study with detailed acceptance criteria and performance data for the specific device being cleared.
• Lack of Specific Study Details: The letter refers to a "premarket notification" but does not include the actual study design, results, or statistical analysis.

Therefore, I cannot extract the requested information from this document. The document only provides the basic details of the clearance process, such as the device name, regulation number, product code, and the date of clearance. It also includes the intended use statement.

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