Withings Smart Body Scale
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121971 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 Withings Smart Body Scale is a Body Composition Analyzer designed to measure and assess body metrics. It provides quantitative data on body weight, fat percentage, muscle mass, water content, and bone density through impedance analysis, enabling users to track health-related parameters over time.
This device is intended for home use and is supplied as a non-sterile, single-use or reusable (depending on model) consumer health tool. It operates without MRI restrictions and is available in multiple reference codes as listed in the regulatory submissions. Authorised under FDA 510(k) clearance and EU MDR, it adheres to regulatory standards for Class II medical devices under the classification Analyzer, Body Composition.
Frequently asked questions
What types of body metrics does the Withings Smart Body Scale measure, and how does it work?
The Withings Smart Body Scale measures body weight, fat percentage, muscle mass, water content, and bone density using impedance analysis. This non-invasive method sends a small electrical current through the body to estimate these metrics, allowing users to track health-related parameters over time for home monitoring.
Is the Withings Smart Body Scale intended for clinical or home use, and what are its sterility and reuse requirements?
The Withings Smart Body Scale is designed for home use as a consumer health tool. It is supplied as non-sterile, and its reuse depends on the specific model—some versions are intended for single-use, while others are designed for reusable home monitoring. Always follow manufacturer guidelines for cleaning and maintenance.
Does the Withings Smart Body Scale have any restrictions on use in medical imaging environments like MRI?
No, the Withings Smart Body Scale is MRI-safe and does not have any restrictions for use in MRI environments. This makes it suitable for users who may need to undergo magnetic resonance imaging without concerns about interference or safety risks.
What regulatory approvals does the Withings Smart Body Scale hold, and under which classification is it categorized?
The Withings Smart Body Scale is authorized under FDA 510(k) clearance and EU MDR (Medical Device Regulation). It is classified as a Class II medical device under the category *Analyzer, Body Composition*, adhering to regulatory standards for body composition analyzers.
Are there multiple models or variations of the Withings Smart Body Scale, and how would I identify the correct one for my needs?
Yes, the Withings Smart Body Scale is available in multiple regulatory reference codes, indicating different models or variations. While the core functionality remains the same (body composition analysis), specific features or technical specifications may vary slightly between versions. Check the manufacturer’s documentation or contact support to confirm compatibility with your intended use, such as single-use vs. reusable designs.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K121971 | Class II | Active |
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Manufacturer
- Manufacturer
- Zhongshan Transtek Electronics Co., Ltd
- FDA Applicant
- Zhongshan Transtek Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K121971 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026