510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022241Substantially Equivalent

Vertis Pnt Control Unit, Model Cu 100; Vertis Pnt Safeguide-Cervical, Model Sg 102-Xxx

Vertis Neuroscience, Inc., Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022241 is the FDA 510(k) clearance record for VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX, a class II device, cleared for Vertis Neuroscience, Inc. on under FDA product code NHI (Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief). FDA's definition for product code NHI reads: "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...". FDA records list 2 510(k) clearances for Vertis Neuroscience, Inc., from to . As of , FDA records show no recalls naming K022241.

Clearance record

Decision date
Received
(62 days to decision)
Product code
NHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Vertis Neuroscience, Inc. 2101 Fourth Ave. Suite 200, Seattle WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NHI

Trailing 12 months

FDA records hold no clearances under product code NHI in the trailing twelve months.

FDA records show no clearances under product code NHI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NHI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260