inforMED
QGTClass II

Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Neurology · 21 CFR 882.5899

A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.

MDR events6All time
Recalls1All time
Registered firms8Currently listed
510(k) clearances7All time

Recent MDR events

6 adverse event reports on file

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Event type breakdown

Injury3
Malfunction3

Most-reported manufacturers

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Theranica Bio-electronics Ltd.4Theranica Bio-electronics Ltd2

Recalls

1 recall events for this product code

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Registered firms

8 firms currently registered for this product code

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510(k) clearances

7 clearances for this product code

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