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510(k) Data Aggregation
K Number
K030203Device Name
LONG WELL LW-6DXX SERIES BODY FAT ANALYZER
Manufacturer
Date Cleared
2003-04-21
(90 days)
Product Code
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
LONG WELL ELECTRONICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is a noninvasive bioimpeadance analyzer used to estimate body fat percentage in home use. The device is for normal, healthy person only, and the applicable age range is 10 to 80 years old.
The device is to be used in the ENVIRONMENT of room temperature & normal environment condition.
Device Description
LONG WELL LW-6Dxx Series Body Fat Analyzer is a hand-held, non-sterile, reusable Body Fat Analyzer intended for estimation of the body fat of percentage in the home.
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