Identifiers
- 510(k) Number
- K112932 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)
TRANSTEK is a body composition analyzer device manufactured by Zhongshan Transtek Electronics Co., Ltd. It is classified as a Class II medical device and falls under the cardiovascular medical specialty category.
The device is supplied by Zhongshan Transtek Electronics Co., Ltd. and has received FDA 510(k) clearance with the K number K112932. It is authorized for use in cardiovascular applications and is regulated under product code MNW.
Frequently asked questions
What is the TRANSTEK body composition analyzer used for?
The TRANSTEK body composition analyzer is a Class II medical device designed for cardiovascular applications. It helps analyze body composition parameters relevant to cardiovascular health assessment and monitoring.
How is the TRANSTEK body composition analyzer supplied?
The TRANSTEK body composition analyzer is supplied directly by its manufacturer, Zhongshan Transtek Electronics Co., Ltd. The device is distributed with appropriate documentation and specifications for clinical use.
What regulatory approvals does the TRANSTEK body composition analyzer have?
The TRANSTEK body composition analyzer has received FDA 510(k) clearance with K number K112932. It is classified as a Class II medical device under product code MNW and is authorized for cardiovascular applications.
Is the TRANSTEK body composition analyzer reusable or single-use?
The device data does not specify whether the TRANSTEK body composition analyzer is designed for single-use or multiple uses. This information would be detailed in the product's instructions for use provided by the manufacturer.
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: Guangdong Transtek Medical Electronics Co., Ltd., About Transtek - Guangdong Transtek Medical Electronics Co.,Ltd., Zhongshan Transtek Electronic Co., Ltd - Made-in-China.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112932 | Class II | Active |
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Manufacturer
- Manufacturer
- Zhongshan Transtek Electronics Co., Ltd
- FDA Applicant
- Zhongshan Transtek Electronics Co., Ltd.
Sources (1)
- FDA 510(k) K112932 24 fields · synced Sep 27, 2026