Search Results

The device may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The "CHUNG CHENG " Far Infrared Ray healthful Lamp (or Medical FIR Radiator) Model #CH-8810 can be used to emit topical heating to the body of human. The device make use of a "All In One" Automatic control Temperature Ceramic Semiconductor. Emission spectrum ranges from 4 to 14 microns. The device uses 120Vac as power source & 800W . it meets the related requirement of IEC 60601-1 Electrical Safety.

The provided text is a 510(k) summary for a medical device called the "CHUNG CHENG" Far Infrared Ray healthful Lamp (Model #CH-8810). It aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested sections about acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable to this type of submission. The device is being cleared based on its similarity in intended use and technological characteristics to an already legally marketed device, and conformity to applicable electrical safety standards.

Here's a breakdown of what can be extracted and what is not available from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document as it's a 510(k) summary focused on substantial equivalence, not a detailed performance study against specific acceptance criteria. The performance summary only states: "The device conforms to applicable standards includes IEC 60601-1, IEC 60601-1-2 & related standards ---- etc." This indicates compliance with electrical safety and electromagnetic compatibility standards, not clinical performance metrics like sensitivity, specificity, or reader agreement.

2. Sample size used for the test set and the data provenance:

Not applicable/Not provided. This document does not describe a clinical test set or study involving human participants to evaluate performance metrics. The clearance is based on comparison to a predicate device and bench testing for electrical safety.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. No clinical test set requiring expert ground truth is mentioned.

4. Adjudication method for the test set:

Not applicable/Not provided. No clinical test set is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable/Not provided. This device is an infrared lamp for topical heating, not an AI-powered diagnostic or assistive technology for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/Not provided. This is not an algorithm-based device.

7. The type of ground truth used:

Not applicable/Not provided. No clinical ground truth is established for this type of device. The "ground truth" for its safety and effectiveness is established by its substantial equivalence to a predicate device and compliance with relevant safety standards.

8. The sample size for the training set:

Not applicable/Not provided. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable/Not provided. Not an AI/machine learning device.

Summary of Device and Evidence for Substantial Equivalence:

The "CHUNG CHENG" Far Infrared Ray healthful Lamp (Model #CH-8810) is an infrared heating lamp intended for:

• Temporary relief of minor muscle and joint pain and stiffness.
• Temporary relief of joint pain associated with arthritis.
• Temporary increase in local circulation where applied.
• Relaxation of muscles.
• Assistance with muscle spasms, minor sprains and strains, and minor muscular back pain.

The study proving the device meets acceptance criteria (in the context of a 510(k) clearance) is the bench testing that demonstrated compliance with applicable standards (IEC 60601-1, IEC 60601-1-2 & related standards for electrical safety) and the comparison to a predicate device.

• Predicate Device: FIRARD II/ TDP LAMP (K960036) marketed by HELIO MEDICAL SUPPLIES, INC.
• Basis for Substantial Equivalence: The submission states that the new device has "the same intended use and similar technological characteristics" as the predicate device. It further claims that "bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." This means the product's safety and effectiveness are inferred from its similarity to an already approved device and its adherence to relevant safety standards.

Ask a specific question about this device