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510(k) Data Aggregation
K Number
K213802Device Name
StimOnTM Pain Relief System (GM2439)
Manufacturer
Gimer Medical Co., Ltd.
Date Cleared
2022-08-26
(263 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Gimer Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
StimOn™ Pain Relief System (GM2439) is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain.
Device Description
StimOn™ Pain Relief System (GM2439) is a hand-held stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves. It may be used as a TENS device to aid the blocking of pain signals traveling to the brain.
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