# K022241: Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXX

- Pathway: 510(k) (Traditional)
- Applicant: Vertis Neuroscience, Inc.
- Decided: Sep 11, 2002 after 62 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: 3 generations back to K881114 (1988). 10 ancestors in all.
13 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)
- K011702: Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx, Vertis Neuroscience, Inc. (2001)
- K970203: Epix VT, Empi (1997) Summary page 2.
- K951903: Epix XL Tens Unit, Empi (1996) Summary page 2.
- K982410: SMP-Plus,SX-Plus,SX Model # 49XX Series 9 Volt Tens Device, Rehabilicare, Inc. (1998) Summary page 2.

## Most influential descendants
- 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
- K181422: SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit (2018), 6 descendants of its own

## Indications for use
Percutaneous Neuromodulation Therapy (PNT) is indicated for the symptomatic relief and management of chronic or intractable pain and/or as an adjunctive treatment in the management of post-surgical pain and post-trauma pain. The PNT Control Unit is to be used with PNT Lumbar Safeguides for low back pain or PNT Cervical Safeguides for neck and/or upper back pain.

Source page: https://510kreport.com/device/K022241
Methodology: https://510kreport.com/methodology