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This document summarizes the 510(k) premarket notification for the CHOYANG Thermal Massager, detailing its intended use, device information, equivalency to predicate devices, and regulatory compliance.

How to fill out choyang formrmal massager 510k

How to fill out CHOYANG Thermal Massager 510(k) Summary

1. Gather necessary information about the CHOYANG Thermal Massager including its intended use, components, and design.
2. Review the FDA guidelines for 510(k) submissions to understand the required format and content.
3. Provide detailed descriptions of the device, including its technology, mechanisms, and any new features.
4. Identify and provide evidence of the device's intended use and any claims made about its effectiveness.
5. Compile data from preclinical testing or clinical studies that support safety and efficacy.
6. Include comparisons with predicate devices, highlighting similarities and differences.
7. Document any potential risks and how they will be mitigated.
8. Ensure all information is clear, concise, and organized according to FDA formatting standards.
9. Review the summary to ensure all required information is included before submission.
10. Submit the 510(k) Summary along with the necessary fees to the FDA.

Who needs CHOYANG Thermal Massager 510(k) Summary?

1. Manufacturers of the CHOYANG Thermal Massager who want to market their product in the U.S.
2. Healthcare professionals or providers looking for evidence-based devices for patient therapy.
3. Distributors seeking to understand the regulatory status of the Thermal Massager.
4. Regulatory professionals preparing documentation for compliance with FDA standards.

People Also Ask about

Where not to use vibrating massager?

Always do your best to vibrate the massager only over muscles. Avoid joints and bones, especially if you have any type of arthritis.

What are the benefits of a thermal massage bed?

2:38 5:25 So typically on the extremities. The low back works really well. But I love to do it on my calfMoreSo typically on the extremities. The low back works really well. But I love to do it on my calf muscle. So that's where we're going to do it. Today i'm going to turn on the here this is the low mode.

How do you use a thermal massager?

3:29 6:13 Button once in manual mode. Move the internal projector by toggling between the up or down buttons.MoreButton once in manual mode. Move the internal projector by toggling between the up or down buttons. To apply soothing heat to a concentrated.

What is thermo massage?

Thermal massage is a therapeutic practice that combines traditional massage and heat, usually using hot stones or bags of hot herbs. Thermal massage contributes to a person's comprehensive well-being.

How many minutes should I use infrared massager?

The massage intensity can be altered by pressing more or less firmly with the massage device. Do not massage a certain site of the body for longer than 3 minutes and then change to other area of the body. After using for a maximum of 15 minutes, unplug the device and let it cool down.

For pdfFiller’s FAQs

What is CHOYANG Thermal Massager 510(k) Summary?

The CHOYANG Thermal Massager 510(k) Summary is a document submitted to the FDA that provides information about the safety and effectiveness of the CHOYANG Thermal Massager, detailing its intended use, technological characteristics, and performance data.

Who is required to file CHOYANG Thermal Massager 510(k) Summary?

Manufacturers or importers of the CHOYANG Thermal Massager are required to file the 510(k) Summary to ensure that the device complies with FDA regulations before it can be marketed.

How to fill out CHOYANG Thermal Massager 510(k) Summary?

To fill out the CHOYANG Thermal Massager 510(k) Summary, the applicant must provide details such as the device description, intended use, substantial equivalence to existing devices, labeling, and performance testing results.

What is the purpose of CHOYANG Thermal Massager 510(k) Summary?

The purpose of the CHOYANG Thermal Massager 510(k) Summary is to demonstrate to the FDA that the device is safe and effective for its intended use and is equivalent to a legally marketed device.

What information must be reported on CHOYANG Thermal Massager 510(k) Summary?

The CHOYANG Thermal Massager 510(k) Summary must report information including device identification, indications for use, technological characteristics, clinical data, and labeling information to establish its safety and effectiveness.