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510(k) Data Aggregation
K Number
K131933Device Name
ELECTRONIC PULSE MASSAGER
Manufacturer
Date Cleared
2013-12-20
(176 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
GURIN PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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
The Santamedical Pulse Stimulator, a Transcutaneous Electrical Nerve Stimulator (TENS), is for overthe-counter use and for home use, which is intended to relieve pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg, due to strain from exercise or normal household and work activities. The portable and microprocessor-controlled Santamedical Pulse Stimulator delivers a gentle electrical pulse through two channels with four attachment pads and shows graphic information about mode style, intensity and time remaining on a LCD based display which is incorporated within the device body.
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