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510(k) Data Aggregation
K Number
K121757Device Name
HEALTHMATEFOREVER
Manufacturer
HEALTHMATE INTERNATIONAL, LLC
Date Cleared
2012-11-20
(158 days)
Product Code
NUH, NGX
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
HEALTHMATE INTERNATIONAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS: 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.
PMS: It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Device Description
Pro-8AB is portable; battery powered (3.7V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device. Double or single channel that effectively transfer 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 6 modes of operations.
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