Cleared Traditional

K031115 - RH-900
(FDA 510(k) Clearance)

K031115 · Iomed, Inc. · Physical Medicine

Jul 2003

Decision

93d

Days

Class 2

Risk

K031115 is an FDA 510(k) clearance for the RH-900. 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 July 10, 2003, 93 days after receiving the submission on April 8, 2003.

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

Submission Details

510(k) Number	K031115 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 2003
Decision Date	July 10, 2003
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF