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510(k) Data Aggregation
K Number
K171071Device Name
StimSox(TM) System
Manufacturer
Date Cleared
2017-08-09
(121 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
StimMed, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The StimSox™ System is indicated to temporarily increase local blood circulation in healthy leg muscles and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Device Description
The StimSox™ System is comprised of a battery powered electrical stimulator, disposable gel electrodes, two left foot boots, two right foot boots, and three AAA batteries.
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K Number
K151922Device Name
StimSox(TM) System
Manufacturer
Date Cleared
2016-04-15
(277 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
StimMed, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To temporarily increase local blood circulation in healthy leg muscles.
Device Description
The StimSox™ System is comprised of a battery powered electrical stimulator, disposable gel electrodes, two left foot boots, two right foot boots, three AAA batteries and user manual. The StimSox™ Stimulator software is embedded firmware written for a microcontroller. The software in the StimSox™ Stimulator is for input controls and output display. There is no operating system. It is a real-time loop that is event driven based on the three buttons on the box.
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