510(k) K201824

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

October 23, 2020

Date Received

July 1, 2020

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Device Class

Class II

Regulation Number

882.5899

Review Panel

NE

Submission Type

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.