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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 UPS-4161780-0/1/1


Manufacturer FEI3009202866
Manufacturer NameBeijing RL Science and Technology Co. Ltd.  
Manufacturer Address line 1306 Lingdi Office Building  
Manufacturer Address line 2Beiyunad Rd, Chaoyang Distric  
Manufacturer's CityBeijing  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code89IMJ  
FDA Product DescriptionDIATHERMY, SHORTWAVE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT  
Refusal Date10-Nov-2011  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-4161780-0/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
NO PMA   501(f)(1)(B), 801(a)(3); ADULTERATION   The article appears to be a class III device without an approved application for premarket approval pursuant to section 515(a).  
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).  
REGISTERED   502(o), 801(a)(3); MISBRANDING   It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).  
RX DEVICE   502(a),(f)(1), 801(a)(3); MISBRANDING   The article appears to be a prescription device without a prescription device legend as required by 21 CFR 801.109.  
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