Cleared Traditional

K180627 - Macroduct Advanced Model 3710
(FDA 510(k) Clearance)

K180627 · Elitechgroup, Inc. · Physical Medicine
Jul 2018
Decision
140d
Days
Class 2
Risk

K180627 is an FDA 510(k) clearance for the Macroduct Advanced Model 3710. This device is classified as a Device, Iontophoresis, Specific Uses (Class II — Special Controls, product code KTB).

Submitted by Elitechgroup, Inc. (Logan, US). The FDA issued a Cleared decision on July 27, 2018, 140 days after receiving the submission on March 9, 2018.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.

Submission Details

510(k) Number K180627 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2018
Decision Date July 27, 2018
Days to Decision 140 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code KTB — Device, Iontophoresis, Specific Uses
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5525