# K052289: Deepwave Neuromodulation Pain Therapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Biowave Corporation
- Decided: Dec 13, 2005 after 112 days
- Product code: LIH (Interferential Current Therapy)
- 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: 1 generation back to K982828 (1998). 1 ancestor in all.
13 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982828: Forte, Models CPS 400 Stim, CPS 200 Stim, Chattanooga Group, Inc. (1998) Summary page 1.

## 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
The Deepwave Neuromodulation Pain Therapy Device is indicated for: * Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic acute pain; * Symptomatic relief of post-traumatic acute pain * Symptomatic relief of post-operative pain

Source page: https://510kreport.com/device/K052289
Methodology: https://510kreport.com/methodology