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Traditional 510(k) Notification MS-120 Electric Stimulator Nixon Wooden America, Inc. July 25, 2011 1110×10 510(k) Summary Company Name: Nixon Wooden Corporation 90 Icon Street Foothill Ranch, CA

How to fill out traditional 510k notification

How to fill out traditional 510k notification?

1. Gather all necessary information and documentation related to the device and its intended use.
2. Complete the Form FDA 3514, which includes sections for identifying information, device description, and intended use.
3. Provide information on the device's performance characteristics and any studies or tests conducted.
4. Include a comparison to a legally marketed device, demonstrating that the device is as safe and effective.
5. Clearly articulate any differences between the device and the legally marketed device, and explain why these differences do not affect its safety or effectiveness.
6. Submit the completed Form FDA 3514, along with the necessary supporting documents, to the FDA for review.

Who needs traditional 510k notification?

1. Manufacturers of medical devices that are not considered exempt from the premarket notification requirements.
2. Manufacturers who have made modifications to their device that could significantly affect its safety or effectiveness.
3. Manufacturers introducing a new device that is similar to an already legally marketed device but has differences that may impact its performance.

Overall, any manufacturer seeking to market a medical device in the United States that falls within the scope of the 510k premarket notification process needs to submit a traditional 510k notification.

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What is traditional 510k notification?

Traditional 510k notification is a premarket submission made to the US Food and Drug Administration (FDA) to demonstrate that a medical device is substantially equivalent to a device already legally marketed for the same intended use.

Who is required to file traditional 510k notification?

Manufacturers or distributors intending to market a medical device in the US are required to file a traditional 510k notification if the device does not qualify for an exemption or special control.

How to fill out traditional 510k notification?

To fill out a traditional 510k notification, the applicant needs to provide information on the device's intended use, technological characteristics, performance data, and any applicable labeling or instructions for use. A detailed submission should be made following the FDA's guidance and format requirements.

What is the purpose of traditional 510k notification?

The purpose of traditional 510k notification is to demonstrate that a new medical device is as safe and effective as a legally marketed predicate device and does not raise additional safety or effectiveness concerns.

What information must be reported on traditional 510k notification?

A traditional 510k notification must include information on the device's intended use, substantial equivalence to a predicate device, device description, performance data, labeling, and any applicable software or accessories.