Is the parent company a U.S. entity acting through a Hong Kong-based agent? I am interested in the red light therapy device, but the FDA Class II listing does not display the full certificate, and I am unable to understand it. Please provide the following information so I can verify that the device is safe for long-term use:
1) The U.S. company’s Certificate of Incorporation
2) FDA registration number or 510(k) number
3) The product’s “Intended Use Statement”
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Is the parent company a U.S. entity acting through a Hong Kong-based agent? I am interested in the red light therapy device, but the FDA Class II listing does not display the full certificate, and I am unable to understand it. Please provide the following information so I can verify that the device is safe for long-term use:
1) The U.S. company’s Certificate of Incorporation
2) FDA registration number or 510(k) number
3) The product’s “Intended Use Statement”