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510(k) Data Aggregation
K Number
K070931Device Name
MODEL PMT850
Manufacturer
Date Cleared
2007-05-24
(51 days)
Product Code
Regulation Number
890.5290Why did this record match?
Applicant Name (Manufacturer) :
PROMEDTEK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Model PMT850 is indicated for adjunctive use in the palliative treatment of postoperative edema and pain in superficial soft tissue.
Device Description
The Model PMT850 device is a pulsed shortwave diathermy device. The Model PMT850 system consists of a Generating Unit connected by a cable to the Treatment Applicator. The Treatment Applicator and cable are a single unit which is connected or disconnected easily from the Generating Unit. The Generating Unit connects to a standard AC electrical outlet by a grounded 3-prong UL/CSA approved, medically rated electric cord.
Treatment with the Model PMT850 requires placing the Treatment Applicator on top of any standard dressing over the area to be treated, setting the dials on the Generating Unit, and turning the device on. There are 6 possible pulse frequency and 6 possible power control settings on the generating unit of the Model PMT850, providing 36 setting options for treatment. Suggested treatment settings are discussed in the Operating Manual for the Model PMT850.
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