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Transtek Body Fat Analyzer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130311

by Guangdong Transtek Medical Electronics Co., Ltd

Identifiers

510(k) Number
K130311 FDA 510(k)
FDA Product Code
MNW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2770 FDA 510(k)
Regulation Number
870.2770 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Transtek Body Fat Analyzer is a medical device classified as an Analyzer for Body Composition. It measures and evaluates body composition metrics, including body fat percentage, muscle mass, hydration levels, and bone mass, providing quantitative assessments for clinical or wellness applications.

This device is supplied as a reusable, non-sterile Class II medical device with FDA 510(k) clearance under the traditional pathway. It operates in clinical or home settings and is intended for single-user use per session. The analyzer includes multiple registration numbers (e.g., 3009253624) and adheres to regulatory standards under 870.2770. No MRI safety information is specified.

Frequently asked questions

Is the Transtek Body Fat Analyzer designed for clinical or home use, and how does that affect its intended user session limits?

The Transtek Body Fat Analyzer is approved for use in both clinical and home settings. It is explicitly intended for single-user use per session, meaning one individual should operate it at a time, regardless of whether it’s in a healthcare facility or a personal wellness environment.

What metrics does the Transtek Body Fat Analyzer measure, and how might these be useful in clinical or wellness applications?

The device quantifies body fat percentage, muscle mass, hydration levels, and bone mass, providing a comprehensive assessment of body composition. These metrics are valuable for clinicians tracking patient health trends (e.g., obesity management, nutritional planning) and for wellness users monitoring fitness progress or metabolic health.

How is the Transtek Body Fat Analyzer supplied, and what does that mean for maintenance or reprocessing?

The analyzer is supplied as a reusable, non-sterile device. Since it’s not sterile, it cannot be used in procedures requiring sterile conditions (e.g., surgical settings). Users must follow manufacturer guidelines for cleaning and maintenance to ensure accuracy and longevity, though no sterilization is required.

Does the Transtek Body Fat Analyzer have any specific regulatory or advisory committee associations, and what does that imply about its development pathway?

The device was cleared via the FDA’s traditional 510(k) pathway under the Cardiovascular (CV) advisory committee and classified under product code MNW (Medical Specialty: Body Composition). This implies it underwent a comparative review to a predicate device and was deemed substantially equivalent in safety and performance, with no direct indication of MRI safety requirements.

Are there multiple models or registration numbers for the Transtek Body Fat Analyzer, and what does that signify for buyers?

Yes, the device lists multiple registration numbers (e.g., 3009253624, 3011065399, etc.), which may correspond to variations in software, firmware, or regional compliance requirements. Buyers should verify the specific model’s features and regulatory compliance with the manufacturer, as these numbers reflect different submissions or iterations under the same product classification.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Body Fat Scale - Guangdong Transtek Medical Electronics Co., Ltd., 2026 Body Scale - Guangdong Transtek Medical Electronics Co., Ltd ..., Guangdong Transtek Medical Electronics Co., Ltd., Transtek Bluetooth Body Fat Scale with APP 180kg

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Guangdong Transtek Medical Electronics Co., Ltd
FDA Applicant
Guangdong Transtek Medical Electronics Co., Ltd.

Sources (1)

  • FDA 510(k) K130311 24 fields · synced Oct 6, 2026