Home
Forms Library
K II- 2 - accessdata fda

K II- 2 - accessdata fda 2025

K II- 2 - accessdata fda Preview on Page 1

See details

4 out of 5

31 votes

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.

Here's how it works

01. Edit your form online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send it via email, link, or fax. You can also download it, export it or print it out.

How to use or fill out K II- 2 - accessdata fda with our platform

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Click ‘Get Form’ to open the K II- 2 - accessdata fda document in the editor.
Begin by filling out the submitter's information section. Enter your name, address, phone number, and contact details accurately.
Proceed to the device information section. Input the trade name, common name, and classification name of your device as specified.
In the classification section, ensure you enter the production code and regulation number correctly to maintain compliance.
Complete the device description by detailing how the Wi-Fi body scale operates and its intended use for measuring various body metrics.
Finally, review all sections for accuracy before saving or exporting your completed form for submission.

Start using our platform today to streamline your document editing and form completion process for free!

be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What is an FDA K number?

A 510(k) is a premarket submission made to the FDA. It is called a 510(k) because it refers to that section of the Food, Drug and Cosmetic Act. It is the regulatory pathway mostly utilized for Class II devices that hope to be substantially equivalent to another device which is currently legally marketed.

What is a class II recall by the FDA?

FDA Recall Classes Defined In a Class-I recall there is a potential for serious injury or death. Class II Recalls are issued on products that have a lower chance of causing major injuries or death, but where there is still the possibility of serious enough adverse events to have irreversible consequences.

How to get FDA 510 K approval?

To obtain 510(k) clearance, a medical device manufacturer submits a package of documents to FDA for review. The objective of the documentation is to support the substantial equivalence of the new device to one that is already on the market (known as a predicate device).

What is a FDA class II device?

Class II medical devices pose a moderate to high risk to patients and/or intended users and require a premarket 510(k) submission, whereas Class III devices pose a high risk and require more extensive clinical evidence in the form of a premarket approval (PMA).

What does FDA category 2 mean?

The FDAs starting point is Section 513(a) of the Federal Food, Drug, and Cosmetic Act, which instructs the agency to match every device with the lowest level of control that still provides reasonable assurance of safety and effectiveness. If general controls alone are insufficientbut full Premarket Approval would

Is 510 K the same as FDA approval?

Its important to note that clearance under the 510(k) pathway does not indicate that the FDA has approved the device but rather that the FDA has determined the device is equivalent to a similar device already on the market.

K II- 2 - accessdata fda 2025

Here's how it works