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510(k) Data Aggregation
K Number
K072276Device Name
SUBDERMAL NEEDLE ELECTRODES
Manufacturer
XIAN FRIENDSHIP ELECTRONICS CO.,LTD.
Date Cleared
2008-05-16
(275 days)
Product Code
GXZ
Regulation Number
882.1350Why did this record match?
Applicant Name (Manufacturer) :
XIAN FRIENDSHIP ELECTRONICS CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction. The electrodes are sterile and for single patient use only.
Device Description
Xian Friendship Electronics Co., Ltd.s' Subdermal Needle Electrodes are disposable (for "Single Use Only"),sterile devices used to detect electrophysiological signals or provide electrical stimulation subcutaneously.
The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient. The subdermal needle electrode is comprised of a small gauge stainless steel needle on one end electrically connected to lead wire and a "touch-proof safety connector on the other end. The needle is inserted subdermally by a licensed physician or technologist under the supervision of a physician. The safety connector is connected to recording or monitoring equipment.
The safety connector is an industry standard DIN 42802 protected, "touch proof connector and cannot be connected to an AC outlet.
Electrodes are used in clinical electro-diagnostic studies or intraoperative monitoring which may include electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation.
Subdermal Needle Electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician.
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