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510(k) Data Aggregation
K Number
K183371Device Name
Deka Tiac 1
Manufacturer
El..En. Electroic Engineering SpA
Date Cleared
2019-12-03
(362 days)
Product Code
PBX
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
El..En. Electroic Engineering SpA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEKA TIAC1 RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The DEKA TIAC 1 massage device is intended to provide a temporary reduction in the appearance of cellulite.
Device Description
The DEKA TIAC 1 is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite.
The DEKA TIAC 1 consists of the following main components:
- microprocessor-driven control unit
- high-frequency electromagnetic energy generator
- user interface with 10.4" color touch screen
- 2 RF handpieces for application of radiofrequency
- 2 integrated massaging balls handpieces
Contact quality monitoring system is present for monitoring of the contact quality under the RF handpiece electrodes.
The electrical specifications are 100-240Vac, 50/60Hz, 1500VA.
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