# K011702: Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx

- Pathway: 510(k) (Traditional)
- Applicant: Vertis Neuroscience, Inc.
- Decided: Dec 21, 2001 after 203 days
- Product code: NHI (Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K881114 (1988). 9 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970203: Epix VT, Empi (1997) Summary page 1.
- K951903: Epix XL Tens Unit, Empi (1996) Summary page 1.
- K982410: SMP-Plus,SX-Plus,SX Model # 49XX Series 9 Volt Tens Device, Rehabilicare, Inc. (1998) Summary page 1.
- K924666: Intelect IFC2, Chattanooga Group, Inc. (1993) Summary page 1.
- K982902: Peripheral Nerve Stimulation, Medtronic Vascular (1998) Summary page 1.
- K973442: Teca Disposable Monopolar Needle Electrodes, Medelec, Inc. D.B.A. Teca Corp. (1997) Summary page 1.
- K950314: Dantec Monopolar Lumen Electrode (13R18 and 13R19), Dantec Medical, Inc. (1996) Summary page 1.
- K915540: Model 3587A Resume II Lead, Medtronic Vascular (1992) Summary page 1.

## Most influential descendants
- K022241: Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXX (2002), 13 descendants of its own
- K061166: Deepwave Percutaneous Neuromodulation Pain Therapy System (2006), 12 descendants of its own
- K072123: Homewave Neuromodulations Pain Therapy Device (2008), 11 descendants of its own
- K161154: Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs (2016), 9 descendants of its own
- K170902: Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit (2017), 7 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K011702
Methodology: https://510kreport.com/methodology