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K II- 2 - accessdata fda

K II- 2 - accessdata fda 2025

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The document is a 510(k) summary for the Wi-Fi body scale model HS5, submitted by Shenzhen Healthcare Electronic Technology Co., Ltd. It outlines the device's intended use, which includes measuring body weight and estimating body fat, water percentage, muscle mass, bone mass, visceral fat rating, and daily calorie intake using bioelectrical impedance analysis (BIA). The document confirms that the device is substantially equivalent to a predicate device (Body Analysis Scale Model BG 17) and provides details on its safety and effectiveness testing.

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Do class II devices need FDA approval?

The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing.

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K II- 2 - accessdata fda 2025

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