# K061166: Deepwave Percutaneous Neuromodulation Pain Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Biowave Corporation
- Decided: Aug 15, 2006 after 110 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: 4 generations back to K881114 (1988). 13 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022241: Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXX, Vertis Neuroscience, Inc. (2002) Summary page 1.
- K052289: Deepwave Neuromodulation Pain Therapy Device, Biowave Corporation (2005) Summary page 1.

## Most influential descendants
- 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
- K202660: SPRINT PNS System (2021), 5 descendants of its own

## Indications for use
The Deepwave Percutaneous Neuromodulation Pain Therapy System is comprised of a percutaneous electrode array and the Deepwave Neuromodulation Pain Therapy Device. The Deepwave Percutaneous Neuromodulation Pain Therapy System is indicated for: * Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic acute pain; * Symptomatic relief of post-traumatic pain; * Symptomatic relief of post-operative pain.

Source page: https://510kreport.com/device/K061166
Methodology: https://510kreport.com/methodology