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510(k) Data Aggregation
K Number
K181211Device Name
Human Tecar HCR 1002
Manufacturer
Date Cleared
2018-09-10
(126 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
UNIBELL S.r.l
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Human Tecar HCR 1002 is a temporary diathermy device for topical heating in order to increase the patient's tissue temperature for treating: relief of pain, muscle spasms, increase in local circulation. The device has also been designed to provide massage aiming to temporarily reduce the cellulite appearance.
Device Description
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