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510(k) Data Aggregation
K Number
K120835Device Name
DYNATRON THERMOSTIM PROBE-DONE
Manufacturer
DYNATRONICS CORPORATION
Date Cleared
2012-08-20
(153 days)
Product Code
GXY, DYN, ILO
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
DYNATRONICS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A hand held cutaneous electrode to be used with Dynatronics Solaris devices to apply electrical stimulation and apply heat and cooling to the skin
Device Description
The Dynatron ThermoStim probes are used to provide therapeutic electrical stimulation and thermal therapy treatments. The probes consist of a handle with a treatment head and connections for a lead wire and/or circulating water. The probes act as an electrode for therapeutic electrical current provided by a Dynatron Solaris device, or other similar Dynatronics electrical stimulation devices in the delivery of electrical stimulation therapy. The treatment head transfers thermal energy (hot or cold) from circulating water when connected to a Dynatron QUAD7™.
The probes are a passive, manual therapy accessory. Treatment cycles are controlled through previously cleared Dynatronics electrical stimulation and OUAD7 devices.
There are two versions of the probe face - a flat head with a surface area of 11.4 cm2 (1.5," diameter) and a domed head with a surface area of 12.3cm-(1.1" diameter).
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