Cleared Traditional

CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C

K090052 · Johari Digital Healthcare , Ltd. · Neurology
May 2009
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K090052 is an FDA 510(k) clearance for the CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C, a Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety (Class II — Special Controls, product code QJQ), submitted by Johari Digital Healthcare , Ltd. (Boranada, Jodhpur, Rajasthan, IN). The FDA issued a Cleared decision on May 29, 2009, 142 days after receiving the submission on January 7, 2009. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5800.

Submission Details

510(k) Number K090052 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2009
Decision Date May 29, 2009
Days to Decision 142 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

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