Cleared Traditional

IontoDC

K170291 · Soterix Medical, Inc. · Physical Medicine
May 2017
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K170291 is an FDA 510(k) clearance for the IontoDC, a Device, Iontophoresis, Other Uses (Class II — Special Controls, product code EGJ), submitted by Soterix Medical, Inc. (New York, US). The FDA issued a Cleared decision on May 1, 2017, 90 days after receiving the submission on January 31, 2017. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5525.

Submission Details

510(k) Number K170291 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2017
Decision Date May 01, 2017
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code EGJ — Device, Iontophoresis, Other Uses
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5525

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