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As Required by 21 section 807 - accessdata fda

As Required by 21 section 807 - accessdata fda 2025

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The document is a 510(k) summary for various medical devices manufactured by Medihightec Medical Co., Ltd., including TENS/EMS combination units and standalone TENS and EMS devices. It outlines the submitter's details, device specifications, intended uses, substantial equivalency claims against predicate devices, and compliance with safety standards. The devices are intended for pain relief and muscle stimulation through electrical currents applied via electrodes on the skin. The summary concludes that the new devices are substantially equivalent to existing predicate devices in terms of safety and effectiveness.

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What is Section 21 of the CFR?

Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).

In which section of 21 CFR can you find device labeling requirements?

Labeling regulations pertaining to medical devices are found in the following Parts of Title 21 of the Code of Federal Regulations (CFR). General Device Labeling - 21 CFR Part 801. In Vitro Diagnostic Products - 21 CFR Part 809. Investigational Device Exemptions - 21 CFR Part 812.

What is the Code of Federal Regulation 21?

The Code of Federal Regulations Title 21 contains the codified Federal laws and regulations that are in effect as of the date of the publication pertaining to food and drugs, both legal pharmaceuticals and illegal drugs. Sign up for email alerts on CFR Title 21, Food Drugs products, news, and offers.