Soterix Medical Announces FDA 510(k) Clearance for IontoDC™ System

Soterix Medical, Inc. (SMI), the technology leader in non-invasive electrotherapy devices, announced today it has received a 510(k) clearance from U.S. Food & Drug Administration (FDA) for its IontoDC™ device intended to use a direct current to introduce ions of soluble salts or other drugs into the body.

The device, called IontoDC is a battery-operated medical device that uses constant weak Direct Current (upto 2.0 mA) to introduce ions of soluble salts or other drugs into the body for medical purposes. Iontophoresis is used for hyperhidrosis treatment, delivery of local anesthetic before emergent skin puncture or dermatological procedure to reduce pain, administration of fentanyl for patient-controlled analgesia for acute pain, sweat test for the diagnosis of cystic fibrosis, etc.

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