510(k) · Cleared

Cleared

Deepwave Neuromodulation Pain Therapy Device

K052289510(k) TraditionalCleared Dec 13, 2005112-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

Biowave Corporation · LIH Interferential Current Therapy

Cleared on Dec 13, 2005 as substantially equivalent to K982828 (Chattanooga Group, Inc., 1998) after a 112-day review. Its family tree reaches back 1 generation to 1998. 13 later devices descend from it.

Decided: Dec 13, 2005
Review: 112 days
Class: Class II
Product code: LIH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K982828 (1998). 13 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK982828 Forte, Models CPS 400 Stim, CPS 200 StimChattanooga Group, Inc. · 1998
This deviceK052289 Deepwave Neuromodulation Pain Therapy DeviceBiowave Corporation · 2005
Descendant · cites it directly · 12 of its ownK061166 Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006
Descendant · cites it directly · 11 of its ownK072123 Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008
Descendant · cites it directly · 9 of its ownK161154 Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator…Spr Therapeutics, LLC · 2016
Descendant · 2 generations on · 7 of its ownK170902 Sprint System, Single Procedure Kit, Sprint System with Pad II…Spr Therapeutics, LLC · 2017
Descendant · 3 generations on · 6 of its ownK181422 SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT…Spr Therapeutics, Inc. · 2018

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2006high 3 (2021) · low 0 (2007)2026

Most influential descendants

Showing 5 of 13 · See all

K061166Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006 · cites it directly12descendants
K072123Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008 · cites it directly11descendants
K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…Spr Therapeutics, LLC · 2016 · cites it directly9descendants
K170902Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit…Spr Therapeutics, LLC · 2017 · 2 generations on7descendants
K181422SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation…Spr Therapeutics, Inc. · 2018 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K982828	Forte, Models CPS 400 Stim, CPS 200 Stim	Chattanooga Group, Inc.	1998	—
0 (this device)	K052289	Deepwave Neuromodulation Pain Therapy Device	Biowave Corporation	2005	—
+1	K061166	Deepwave Percutaneous Neuromodulation Pain Therapy System	Biowave Corporation	2006	—
+1	K072123	Homewave Neuromodulations Pain Therapy Device	Biowave Corporation	2008	—
+1	K161154	Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…	Spr Therapeutics, LLC	2016	—
+2	K170902	Sprint System, Single Procedure Kit, Sprint System with Pad II, Single…	Spr Therapeutics, LLC	2017	—
+3	K181422	SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve…	Spr Therapeutics, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2009	1	0
2016	1	0
2017	1	0
2018	1	0
2021	3	0
2022	2	0
2023	1	0
2025	1	0

FIG. 1 — Lineage of K052289, 1998–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 LIH? 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 LIH device

#1 K231575 Vecttor VT-300score 7.1 · 2 generations · no Class I recall

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K982828	Forte, Models CPS 400 Stim, CPS 200 Stim Summary page 1 …Stimulator, Interferential Current Stimulator 3. PREDICATE DEVICES Chattanooga Group Forte Model CPS 200 Stimulator Device K982828. 4. INTENDED USE The Deepwave Neuromodulation Pain Therapy Device is indicated for: * Symptomatic relief…	Chattanooga Group, Inc.	1998	—

Also cleared against K982828: 1 other device →

What descends from it? (13)

See all 13

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061166	Deepwave Percutaneous Neuromodulation Pain Therapy System	Biowave Corporation	2006	12
K072123	Homewave Neuromodulations Pain Therapy Device	Biowave Corporation	2008	11
K161154	Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…	Spr Therapeutics, LLC	2016	9

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?

Its one ancestor has no recall.
Of its descendants, K061166 (Biowave Corporation, 2006) has gone furthest, with 12 descendants of its own.
1 other device also cites its predicate K982828.

How does its category compare?

All LIH devices

LIH Interferential Current Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LIH

1in 2024

2007high 2 (2009) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIH

Too few LIH 510(k)s in any year since 2007 to give a median.

Recalls per year · LIH

No recall names LIH since 2007.

Adverse event reports per year · LIH

1in 2025

2007high 14 (2008) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	0	—	14
2009	2	—	3
2010	2	—	2
2011	1	—	1
2012	2	—	1
2013	0	—	1
2014	0	—	0
2015	0	—	1
2016	0	—	1
2017	0	—	1
2018	0	—	0
2019	1	—	1
2020	0	—	0
2021	1	—	1
2022	0	—	0
2023	0	—	0
2024	1	—	1
2025	0	—	1
2026	0	—	—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052289 · printed Nov 4, 2026

Cite this page

510(k) Report. “K052289: Deepwave Neuromodulation Pain Therapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052289

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026