Cleared Traditional

VERTIS PNT CONTROL UNIT, MODEL CU 100 (K022241) - FDA 510(k) Clearance

Also marketed or referenced as:
VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K022241 · Vertis Neuroscience, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
62d
Days
Class 2
Risk

K022241 is an FDA 510(k) clearance for the VERTIS PNT CONTROL UNIT, MODEL CU 100. Classified as Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief (product code NHI), Class II - Special Controls.

Submitted by Vertis Neuroscience, Inc. (Seattle, US). The FDA issued a Cleared decision on September 11, 2002 after a review of 62 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vertis Neuroscience, Inc. devices

Submission Details

510(k) Number K022241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2002
Decision Date September 11, 2002
Days to Decision 62 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
86d faster than avg
Panel avg: 148d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (NHI) and FDA review panel - the closest regulatory comparables to K022241.
SPRINT Peripheral Nerve Stimulation (PNS) System
K223306 · Spr Therapeutics, Inc. · Jan 2023
Primary Relief
K221425 · Dyansys, Inc. · Sep 2022
ANSiStim-PP
K220397 · Dyansys, Inc. · May 2022
Primary Relief
K213188 · Dyansys, Inc. · Jan 2022
First Relief
K212859 · Dyansys, Inc. · Dec 2021
SPRINT PNS System
K211801 · Spr Therapeutics, Inc. · Oct 2021