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510(k) Data Aggregation
K Number
K132563Device Name
PINOOK STIMULATOR
Manufacturer
Date Cleared
2014-04-24
(252 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
PINOOK USA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
The BH - 18 is a portable; battery powered (3.7VDC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device.
Two channels 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, there are 6 modes of operation.
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