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510(k) Data Aggregation
K Number
K220286Device Name
ELECTROCYN soma
Manufacturer
Date Cleared
2022-12-21
(323 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
V3bio Sdn. Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Rx Indications:
Under the supervision of a healthcare professional, ELECTROCYN soma is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic wounds including stage I-IV pressure ulcers, stasis ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minor irritations of the skin and diabetic foot ulcers. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.
OTC Indications:
ELECTROCYN soma is intended for OTC use in the management of skin abrasions, minor irritations, cuts, and intact skin.
Device Description
ELECTROCYN soma contains purified water - 99.9%, hypochlorous acid (HOCl) + sodium hypochlorite (NaOCl) + sodium chloride (NaCl) ~ 0.1% and packed in HDPE bottles.
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