Cleared Traditional

K070412 - ELEXOMA MEDIC

K070412 is an FDA 510(k) clearance for ELEXOMA MEDIC, manufactured by Redplane AG. The device is a Class 2 Neurology device with product code QJQ cleared through the Traditional 510(k) pathway after a 464-day FDA review.

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

K070412 is an FDA 510(k) clearance for the ELEXOMA MEDIC. Classified as Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety (product code QJQ), Class II - Special Controls.

Submitted by Redplane AG (Zug, CH). The FDA issued a Cleared decision on May 21, 2008 after a review of 464 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5800 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K070412

510(k) Number K070412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
315d slower than avg
Panel avg: 149d · This submission: 464d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QJQ Device Classification - Class 2, Special Controls

Product Code QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5800
Definition To Provide Electrical Current To The Head To Treat Insomnia And/or Anxiety
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety

All 17
Devices cleared under the same product code (QJQ) and FDA review panel - the closest regulatory comparables to K070412.
Modius Sleep
K230826 · Neurovalens , Ltd. · Oct 2023
Cervella
K182311 · Innovative Neurological Devices, LLC · Mar 2019
CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C
K090052 · Johari Digital Healthcare , Ltd. · May 2009
CES ULTRA
K062284 · Neuro-Fitness, LLC · Apr 2007
NET-2000 MICROCURRENT STIMULATOR
K060158 · Auri-Stem Medical, Inc. · Oct 2006
TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1
K024377 · Kalaco Scientific, Inc. · Jul 2003
K070412 · ELEXOMA MEDIC
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