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510(k) Data Aggregation
K Number
K211207Device Name
Diacare 7000
Manufacturer
Date Cleared
2022-06-06
(410 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Globus Sport and Health Technologies LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Diacare 7000 is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
Device Description
The Diacare 7000 is a diathermy device that generates a high frequency sinusoidal current with a monopolar and bipolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a hand-held electrode is manipulated by a therapist. When the electrode is in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in capacitive and resistive monopolar modes. The Diacare 7000 consists of a power console on LCD monitor, and accessories including capacitive and resistive bipolar and monopolar electrodes. The unit can be adjusted to provide various levels of treatment from 400 KHz to 1.2 MHz.
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