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510(k) Data Aggregation
K Number
K132993Device Name
COUNTER OTC TENS DEVICE
Manufacturer
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD.
Date Cleared
2014-04-24
(212 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This TENS Device is to be used for temporary relief of pain associated with sore or aching muscles of lower back, arms, or legs due to strain from exercise or normal household and work activities.
Device Description
The Counter Pain Therapy Device, Model P.T.S.-IV features two channels and seven (7) preset programs. The output of both channels can be adjusted individually for intensity in sixteen (16) steps and the treatment time is selectable from 20, 30 or 40 minutes. All features are well indicated by large icons on a backlit LCD screen for easy reading. The device is powered by three (3) rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied for the device. The Pain Therapy Device consists of the handheld main unit (controller), two pairs of self-adhesive electrodes, a plug-in charging unit (adaptor 120VAC to 5VDC) and two pairs of electrode cables.
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