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510(k) Data Aggregation
K Number
K122410Device Name
I RUNE (I-200L)
Manufacturer
Date Cleared
2013-11-12
(461 days)
Product Code
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
MEDIRUNE CO, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
I-RUNE (1-200 L) is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Device Description
I-RUNE (I-200 L) is a portable pain reliever offering TENS. The channel that effectively transfers your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 7modes of operation.
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