510(k) Report

510(k) · Cleared

Cleared

Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx

K011702510(k) TraditionalCleared Dec 21, 2001203-day reviewClass II21 CFR 882.5890

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vertis Neuroscience, Inc. · NHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

Cleared on Dec 21, 2001 as substantially equivalent to K970203 (Empi, 1997) and 7 other predicates after a 203-day review. Its family tree reaches back 2 generations to 1988. 14 later devices descend from it.

Decided
Dec 21, 2001
Review
203 days
Class
Class II
Product code
NHI
Recalls
None
Predicates
8

Its longest line of descent runs back 2 generations to K881114 (1988). 9 ancestors in all. 14 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 2 other ancestors1997: 1 other ancestor1996: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor2002: 1 descendant cleared2006: 1 descendant cleared2008: 1 descendant cleared2016: 1 descendant cleared2021: 3 descendants cleared2009: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared2023: 1 descendant cleared2018: 1 descendant cleared2022: 2 descendants clearedK881114 · Empi Model 989, Tens · Empi · 1988K970203 · Epix VT · Empi · 19971990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 3 descendants4 generations forward: 5 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 1 descendant8 generations forward: 1 descendant K970203 · Epix VT · Empi · 1997K881114 · Empi Model 989, Tens · Empi · 19880+5
  1. Root · 2 generations backK881114 Empi Model 989, TensEmpi · 1988
  2. 1 generation backK970203 Epix VTEmpi · 1997
  3. This deviceK011702 Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100…Vertis Neuroscience, Inc. · 2001
  4. Descendant · cites it directly · 13 of its ownK022241 Vertis PNT Control Unit, Model CU 100; Vertis PNT…Vertis Neuroscience, Inc. · 2002
  5. Descendant · 2 generations on · 12 of its ownK061166 Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006
  6. Descendant · 3 generations on · 11 of its ownK072123 Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008
  7. Descendant · 3 generations on · 9 of its ownK161154 Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator…Spr Therapeutics, LLC · 2016
  8. Descendant · 4 generations on · 7 of its ownK170902 Sprint System, Single Procedure Kit, Sprint System with Pad II…Spr Therapeutics, LLC · 2017

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2002: 12006: 12008: 12009: 12016: 12017: 12018: 12021: 32022: 22023: 12025: 1
2002high 3 (2021) · low 0 (2003)2026

Most influential descendants

Showing 5 of 14 · See all
  • K022241Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXXVertis Neuroscience, Inc. · 2002 · cites it directly13descendants
  • K061166Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006 · 2 generations on12descendants
  • K072123Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008 · 3 generations on11descendants
  • K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…Spr Therapeutics, LLC · 2016 · 3 generations on9descendants
  • K170902Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit…Spr Therapeutics, LLC · 2017 · 4 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K881114Empi Model 989, TensEmpi1988—
−1K970203Epix VTEmpi1997—
0 (this device)K011702Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, SgxxxVertis Neuroscience, Inc.2001—
+1K022241Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG…Vertis Neuroscience, Inc.2002—
+2K061166Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation2006—
+3K072123Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation2008—
+3K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…Spr Therapeutics, LLC2016—
+4K170902Sprint System, Single Procedure Kit, Sprint System with Pad II, Single…Spr Therapeutics, LLC2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310
199620
199710
199820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200610
200810
200910
201610
201710
201810
202130
202220
202310
202510
FIG. 1 — Lineage of K011702, 1988–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NHI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NHI device

  1. #1 K202660 SPRINT PNS Systemscore 12.1 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K970203Epix VT
Summary page 1
…esident, Regulatory Affairs/ Quality Assurance Substantially Equivalent Devices Manufacturer Substantially Equivalent devices 510(k) Empi, Inc. EPIX Tens Device System K970203 St. Paul, MN Model EPIX VT K951903 Model EPIX XL Rehabilicare, Inc. SMP-Plus™ K982410 New Brighton, MN Model 4930 Chattanooga Gr…
Empi1997—
*K951903Epix XL Tens Unit
Summary page 1
…y Assurance Substantially Equivalent Devices Manufacturer Substantially Equivalent devices 510(k) Empi, Inc. EPIX Tens Device System K970203 St. Paul, MN Model EPIX VT K951903 Model EPIX XL Rehabilicare, Inc. SMP-Plus™ K982410 New Brighton, MN Model 4930 Chattanooga Group, Inc. Intelect ® Legend Stim K9…
Empi1996—
*K982410SMP-Plus,SX-Plus,SX Model # 49XX Series 9 Volt Tens Device
Summary page 1
…acturer Substantially Equivalent devices 510(k) Empi, Inc. EPIX Tens Device System K970203 St. Paul, MN Model EPIX VT K951903 Model EPIX XL Rehabilicare, Inc. SMP-Plus™ K982410 New Brighton, MN Model 4930 Chattanooga Group, Inc. Intelect ® Legend Stim K924666 Hixson, TN Model IFC2 (catalog #INT002) Medtro…
Rehabilicare, Inc.1998—
*K924666Intelect IFC2
Summary page 1
…K970203 St. Paul, MN Model EPIX VT K951903 Model EPIX XL Rehabilicare, Inc. SMP-Plus™ K982410 New Brighton, MN Model 4930 Chattanooga Group, Inc. Intelect ® Legend Stim K924666 Hixson, TN Model IFC2 (catalog #INT002) Medtronic, Inc Mattrix ® Neurostimulation System K982902 Minneapolis, MN Receiver model:…
Chattanooga Group, Inc.1993—
*K982902Peripheral Nerve Stimulation
Summary page 1
…w Brighton, MN Model 4930 Chattanooga Group, Inc. Intelect ® Legend Stim K924666 Hixson, TN Model IFC2 (catalog #INT002) Medtronic, Inc Mattrix ® Neurostimulation System K982902 Minneapolis, MN Receiver model: 3272 Transmitter model: 3210 TECA Corporation TECA Disposable Monopolar Needles | K973442 Pleasa…
Medtronic Vascular1998—
*K973442Teca Disposable Monopolar Needle Electrodes
Summary page 1
…dtronic, Inc Mattrix ® Neurostimulation System K982902 Minneapolis, MN Receiver model: 3272 Transmitter model: 3210 TECA Corporation TECA Disposable Monopolar Needles | K973442 Pleasantville, NY 902-DMFxx-TP series 892-DMGxx-TP series Medtronic, Inc. DMNT™ Disposable Monopolar Needle | K950314 Minneapoli…
Medelec, Inc. D.B.A. Teca Corp.1997—
*K950314Dantec Monopolar Lumen Electrode (13R18 and 13R19)
Summary page 1
…CA Corporation TECA Disposable Monopolar Needles | K973442 Pleasantville, NY 902-DMFxx-TP series 892-DMGxx-TP series Medtronic, Inc. DMNT™ Disposable Monopolar Needle | K950314 Minneapolis, MN Electrodes DMFxx series DMNxx series Medtronic, Inc. Resume II Lead K915540 Minneapolis, MN Model 3587a Intend…
Dantec Medical, Inc.1996—
*K915540Model 3587A Resume II Lead
Summary page 1
…es 892-DMGxx-TP series Medtronic, Inc. DMNT™ Disposable Monopolar Needle | K950314 Minneapolis, MN Electrodes DMFxx series DMNxx series Medtronic, Inc. Resume II Lead K915540 Minneapolis, MN Model 3587a Intended use Percutaneous Neuromodulation Therapy (PNT) is indicated for the symptomatic relief and…
Medtronic Vascular1992—

Also cleared against K970203: 4 other devices →

What descends from it? (14)

See all 14

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022241Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXXVertis Neuroscience, Inc.200213

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K022241 (Vertis Neuroscience, Inc., 2002) has gone furthest, with 13 descendants of its own.
  • 4 other devices also cite its predicate K970203.

How does its category compare?

All NHI devices

NHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NHI

1in 2023

2016: 12017: 12018: 12021: 32022: 32023: 1
2007high 3 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHI

120in 2022

2021: 125 days median2022: 120 days median
2007high 125 (2021) · low 120 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NHI

No recall names NHI since 2007.

Adverse event reports per year · NHI

13in 2025

2016: 12020: 12021: 62022: 82023: 252024: 122025: 13
2007high 25 (2023) · low 0 (2007)2025

MAUDE reports naming product code NHI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20161—01
20171—00
20181—00
20190—00
20200—01
2021312506
2022312008
20231—025
20240—012
20250—013
20260—0—

What is it indicated for?

Percutaneous Neuromodulation Therapy (PNT) is indicated for the symptomatic relief and management of chronic or intractable low back pain and/or as an adjunctive treatment in the management of post-surgical low back pain and

post-trauma low back pain.

The PNT Control Unit is to be used with a PNT Safeguide Kit — Lumbar.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K970203

4 other devices cite the same predicate.

  • K070474Newlife Sciences LLC, Model TMRNewlife Sciences, LLC · 2007
  • K061650Select Tens, Model 4600SEmpi · 2007
  • K032928Mediphysics Pain Treatment System, Model 1Mediphysics Pain Centers of America · 2003
  • K022241Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXXVertis Neuroscience, Inc. · 2002

More from Vertis Neuroscience, Inc.

2 FDA decisions under this applicant name. See the company

  • K022241Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXXVertis Neuroscience, Inc. · 2002

Recent decisions in NHI

The NHI category page

  • K223306SPRINT Peripheral Nerve Stimulation (PNS) SystemSpr Therapeutics, Inc. · 2023
  • K221425Primary ReliefDyansys, Inc. · 2022
  • K220397ANSiStim-PPDyansys, Inc. · 2022
  • K213188Primary ReliefDyansys, Inc. · 2022
  • K212859First ReliefDyansys, Inc. · 2021

https://510kreport.com/device/K011702 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011702: Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011702

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026