Cleared Traditional

K001522 - TRANSQ3
(FDA 510(k) Clearance)

K001522 · Iomed, Inc. · Physical Medicine
Oct 2000
Decision
155d
Days
Class 2
Risk

K001522 is an FDA 510(k) clearance for the TRANSQ3. This device is classified as a Device, Iontophoresis, Specific Uses (Class II — Special Controls, product code KTB).

Submitted by Iomed, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 18, 2000, 155 days after receiving the submission on May 16, 2000.

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

Submission Details

510(k) Number K001522 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2000
Decision Date October 18, 2000
Days to Decision 155 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