Get the free This 510O(k) summary of safety and effectiveness for Shengguang Manual - accessdata fda

510(K) SUMMARY This 510O(k) summary of safety and effectiveness for Shenyang Manual Wheelchair is submitted in accordance with the requirements of SODA 1990 and 21 CFR 807.92 Table I General Information

How to fill out this 510ok summary of

How to fill out this 510ok summary of

1. Read the instructions carefully and understand the purpose of the 510k summary.
2. Gather all the necessary information and documents required for the summary.
3. Start by providing general information about the device, such as the name, manufacturer, intended use, and classification.
4. Identify and describe the predicate devices that are similar to the one being submitted for the 510k summary.
5. Explain the technological characteristics and performance specifications of the device.
6. Provide a detailed description of the intended use and indications for use.
7. Summarize any clinical testing or scientific studies conducted on the device.
8. Include information on the device's safety and effectiveness, addressing any potential risks or hazards.
9. Outline any labeling or instructions for use that accompany the device.
10. Attach any additional supporting documentation, such as test reports or certifications.
11. Review and proofread the completed 510k summary before submission.
12. Ensure all required sections and information are accurately provided.
13. Submit the completed 510k summary to the appropriate regulatory authority.
14. Monitor and respond to any requests for additional information or clarifications from the regulatory authority.

Who needs this 510ok summary of?

1. Medical device manufacturers who are seeking clearance to market a new device in the United States.
2. Companies that have made modifications to an existing device that may require a new 510k submission.
3. Regulatory affairs professionals responsible for preparing and submitting 510k summaries.
4. Individuals or organizations involved in the design, development, or manufacturing of medical devices.
5. Government agencies involved in the regulation and oversight of medical devices.
6. Healthcare professionals who want to stay informed about the safety and effectiveness of medical devices.

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What is this 510ok summary of?

The 510(k) summary is a concise summary of a 510(k) submission providing an overview of the device, its intended use, and a summary of the technological characteristics of the device.

Who is required to file this 510ok summary of?

Manufacturers of medical devices are required to file a 510(k) summary when seeking FDA clearance to market their device.

How to fill out this 510ok summary of?

The 510(k) summary should be filled out by providing detailed information on the device, its intended use, technology, and any similarities to other devices already on the market.

What is the purpose of this 510ok summary of?

The purpose of the 510(k) summary is to provide the FDA with a simplified overview of a device's safety and effectiveness, to determine if it is substantially equivalent to a legally marketed device.

What information must be reported on this 510ok summary of?

The 510(k) summary must include information on the device's design, materials, intended use, technological characteristics, performance, and any clinical data supporting its safety and effectiveness.