Cleared Traditional

K061166 - DEEPWAVE PERCUTANEOUS NEUROMODULATION P...

K061166 is an FDA 510(k) clearance for DEEPWAVE PERCUTANEOUS NEUROMODULATION P..., manufactured by Biowave Corporation. The device is a Class 2 Neurology device with product code NHI cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K061166 · Biowave Corporation · Neurology device
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Aug 2006
Decision
110d
Days
Class 2
Risk

K061166 is an FDA 510(k) clearance for the DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM. Classified as Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief (product code NHI), Class II - Special Controls.

Submitted by Biowave Corporation (North Attleboro, US). The FDA issued a Cleared decision on August 15, 2006 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biowave Corporation devices

FDA 510(k) Submission Details - K061166

510(k) Number K061166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2006
Decision Date August 15, 2006
Days to Decision 110 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 148d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHI Device Classification - Class 2, Special Controls

Product Code NHI Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Percutaneous Electrical Nerve Stimulator (pens) Is A Device Used For The Treatment Of Pain. Unlike The Classified Transcutaneous Electrical Nerve Stimulator That Apply An Electrical Current To Electrodes On A Patient's Skin To Deliver Stimulation, A Pens Uses Electrodes That Are Placed Percutaneously To Deliver Stimulation,
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 - NHI Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief

All 8
Devices cleared under the same product code (NHI) and FDA review panel - the closest regulatory comparables to K061166.
SPRINT PNS System
K211801 · Spr Therapeutics, Inc. · Oct 2021
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K202660 · Spr Therapeutics, Inc. · Jan 2021
SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit
K181422 · Spr Therapeutics, Inc. · Jul 2018