Cleared Traditional

ELEXOMA MEDIC

K070412 · Redplane AG · Neurology
May 2008
Decision
464d
Days
Class 2
Risk

About This 510(k) Submission

K070412 is an FDA 510(k) clearance for the ELEXOMA MEDIC, a Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety (Class II — Special Controls, product code QJQ), submitted by Redplane AG (Zug, CH). The FDA issued a Cleared decision on May 21, 2008, 464 days after receiving the submission on February 12, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5800.

Submission Details

510(k) Number K070412 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 2007
Decision Date May 21, 2008
Days to Decision 464 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code QJQ — Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5800
Definition To Provide Electrical Current To The Head To Treat Insomnia And/or Anxiety