Search Results
Found 1 results
510(k) Data Aggregation
K Number
K112149Device Name
WEIGHT AND BODY FAT SCALE SHINE BS0105
Manufacturer
Date Cleared
2012-04-09
(258 days)
Product Code
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
SHINE OVERSEAS MARKETING LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Shine Overseas Marketing Limited Weight & Body Fat Monitoring Scale, Model BS0105 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass and bones mass using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults (from ages 18-80) who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy.
Device Description
The patient steps on the scale device, where two electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 µA, at 50 kHz, the Shine Overseas Marketing Limited Weight and Body Fat Scale calculates the body fat percentage. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body determines the body fat. The calculation is based upon electrical impedance. height, weight, age, and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. There are elements of this process that can produce erroneous readings, such as dry feet or improper-programmed data. The User's Manual defines items which could cause erroneous readings.
Ask a Question
Ask a specific question about this device
Page 1 of 1