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510(k) Data Aggregation
K Number
K153520Device Name
Electronic Pulse Stimulator
Manufacturer
JKH HEALTH CO.,LTD.
Date Cleared
2016-05-05
(149 days)
Product Code
NUH, NGX, NYN
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
JKH HEALTH CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS (Modes 1, 2, 4, 5, 6)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, arm, and leg, due to strain from exercise or normal household and work activities.
It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS (Modes 1 and 3)
To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Device Description
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