Weight and Body Fat Scale Shine BS0105
by Shine Overseas Marketing Limited
510(k) K112149
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112149 | Date9 Apr 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MNW
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2770
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Weight and Body Fat Scale Shine BS0105 is a bioelectrical impedance analysis (BIA) device designed to measure body weight, body fat percentage, body water, muscle mass, and bone mass. Classified as an Analyzer, Body Composition, it provides quantitative assessments of body composition metrics for clinical and consumer use.
This device is intended for single-use or reusable application in non-clinical settings, such as home or wellness environments. It operates without MRI restrictions and is supplied as a standalone unit. Authorized under FDA 510(k) clearance (K112149) under regulation 870.2770, it adheres to Class II medical device standards. No sterility requirements are specified, and storage conditions are not detailed in the regulatory data.
Questions
AI-generated answers, 19 Sep 2026
What types of body composition metrics does the Shine BS0105 measure, and how might this differ from a traditional scale?
The Shine BS0105 uses bioelectrical impedance analysis (BIA) to measure not just body weight, but also body fat percentage, body water, muscle mass, and bone mass. Unlike a traditional scale, which only provides weight, this device offers quantitative assessments of body composition—helpful for tracking health trends beyond weight alone, such as hydration levels or muscle-to-fat ratios, primarily for non-clinical use like home or wellness settings.
Is the Shine BS0105 designed for clinical use, or is it intended for home or consumer settings?
The device is explicitly intended for non-clinical settings, such as home or wellness environments. While it provides body composition metrics, it is not classified for use in professional healthcare facilities or under clinical supervision. Its design aligns with consumer-grade bioelectrical impedance analysis tools rather than medical-grade diagnostics.
Can this scale be reused, or is it meant for single-use only?
The Shine BS0105 is not specified as single-use; it is designed for single-use or reusable application in non-clinical settings. However, no sterility requirements are mentioned in the regulatory data, so reuse would depend on manufacturer guidelines and user practices to maintain accuracy and hygiene.
What regulatory pathway did the Shine BS0105 follow to gain market authorization, and what does that imply about its safety standards?
The device received FDA 510(k) clearance (K112149) under regulation 870.2770, classified as a Class II medical device. This pathway demonstrates that the manufacturer has shown it is substantially equivalent to a legally marketed predicate device, meeting U.S. safety and performance standards for body composition analyzers. The clearance also reflects adherence to FDA’s requirements for Class II devices, which typically involve general controls and special controls.
Are there any special storage requirements or conditions for the Shine BS0105, or is it intended to be used immediately after purchase?
The regulatory data does not specify any storage conditions for the Shine BS0105. As a standalone, non-clinical device, it is likely intended for immediate use after purchase, but users should follow the manufacturer’s instructions (not detailed here) to ensure optimal performance and longevity, particularly if reused.