Cleared Special

K170926 - BrainPulse 1100

K170926 is an FDA 510(k) clearance for BrainPulse 1100, manufactured by Jan Medical, Inc.. The device is a Class 2 Neurology device with product code POP cleared through the Special 510(k) pathway after a 30-day FDA review.

K170926 · Jan Medical, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
30d
Days
Class 2
Risk

K170926 is an FDA 510(k) clearance for the BrainPulse 1100. Classified as Cranial Motion Measurement Device (product code POP), Class II - Special Controls.

Submitted by Jan Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 28, 2017 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1630 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K170926

510(k) Number K170926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2017
Decision Date April 28, 2017
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 149d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

POP Device Classification - Class 2, Special Controls

Product Code POP Cranial Motion Measurement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1630
Definition A Cranial Motion Measurement Device Is A Prescription Device That Utilizes Accelerometers To Measure The Motion Or Acceleration Of The Skull. These Measurements Are Not To Be Used For Diagnostic Purposes.
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.

K170926 · BrainPulse 1100
Download PDF FDA Summary Jan Medical, Inc.