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510(k) Data Aggregation
K Number
K003130Device Name
REGUTHERM 952 THERMOGRAPHIC SYSTEM
Manufacturer
Date Cleared
2001-02-16
(133 days)
Product Code
Regulation Number
884.2980Why did this record match?
Applicant Name (Manufacturer) :
SIE-MED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K964083Device Name
ULTRATHERM (908)
Manufacturer
Date Cleared
1997-04-03
(174 days)
Product Code
Regulation Number
890.5290Why did this record match?
Applicant Name (Manufacturer) :
SIE-MED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The labeling for the Ultratherm 908i limits its intended uses to those accepted by FDA for class II shortwave diathermy devices.
Device Description
The Ultratherm 908i is a shortwave diathermy device intended to generate deep heat in body tissues for the treatment of medical conditions such as the relief of pain, muscle spasms and joint contractures.
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