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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal 146-0016437-1/3/6


Manufacturer FEI3004897611
Manufacturer NameTwinsonic Enterprise Co. Limited  
Manufacturer Address line 1No. 141 Chang Shui Rd. Sec. 2puyen  
Manufacturer Address line 2  
Manufacturer's CityChang-Hua Hsien  
Manufacturer Province/State  
Manufacturer Country/AreaTaiwan  
Product Code89ISA  
FDA Product DescriptionMASSAGER, THERAPEUTIC, ELECTRIC  
Refusal Date13-Jan-2005  
FDA DistrictSAN-DO  
Entry/doc/line/sfx 146-0016437-1/3/6
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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