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510(k) Data Aggregation
K Number
K131956Device Name
QUICK RELAX PRO
Manufacturer
Date Cleared
2014-04-24
(301 days)
Product Code
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
HEALTHCARE INNOVATIONS, 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
Hand held, 1.5 volt AA battery powered, single mode, single function device with ten "settings" that are controlled by means of rotating a marked disk that increases the microcurrent when rotated clockwise and decreases the microcurrent when rotated counterclockwise, directly through the device integrated electrode into the indicated region of the body. The purpose of the Quick Relax Pro is to provide a temporary relief of minor muscle pain within the indicated region of the body.
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