510(k) · Cleared
ClearedDeepwave Percutaneous Neuromodulation Pain Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biowave Corporation · NHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Cleared on Aug 15, 2006 as substantially equivalent to K022241 (Vertis Neuroscience, Inc., 2002) and 1 other predicate after a 110-day review. Its family tree reaches back 4 generations to 1988. 12 later devices descend from it.
- Decided
- Aug 15, 2006
- Review
- 110 days
- Class
- Class II
- Product code
- NHI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K881114 (1988). 13 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK881114 Empi Model 989, TensEmpi · 1988
- 3 generations backK970203 Epix VTEmpi · 1997
- 2 generations backK011702 Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100…Vertis Neuroscience, Inc. · 2001
- 1 generation backK022241 Vertis PNT Control Unit, Model CU 100; Vertis PNT…Vertis Neuroscience, Inc. · 2002
- This deviceK061166 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
- Descendant · 4 generations on · 5 of its ownK202660 SPRINT PNS SystemSpr Therapeutics, Inc. · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- 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
- K202660SPRINT PNS SystemSpr Therapeutics, Inc. · 2021 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −3 | K970203 | Epix VT | Empi | 1997 | — |
| −2 | K011702 | Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx | Vertis Neuroscience, Inc. | 2001 | — |
| −1 | K022241 | Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG… | Vertis Neuroscience, Inc. | 2002 | — |
| 0 (this device) | 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 | — |
| +4 | K202660 | SPRINT PNS System | Spr Therapeutics, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
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 NHI? 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 NHI device
- #1 K202660 SPRINT PNS Systemscore 12.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K022241 | Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXXSummary page 1…Electrical Nerve Stimulation Devices 3. PREDICATE DEVICES * Vertis NeuroScience Inc., Percutaneous Neuromodulation Control Unit and Accessories (K022241) * Biowave Corporation's Deepwave Neuromodulation Pain Therapy Device (K052289) 4. INTENDED USE The… | 2002 |
| * | K052289 | Deepwave Neuromodulation Pain Therapy DeviceSummary page 1…c., Percutaneous Neuromodulation Control Unit and Accessories (K022241) * Biowave Corporation's Deepwave Neuromodulation Pain Therapy Device (K052289) 4. INTENDED USE The Deepwave Percutaneous Neuromodulation Pain Therapy System is comprised of a percutaneous e… | 2005 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K072123 (Biowave Corporation, 2008) has gone furthest, with 11 descendants of its own.
How does its category compare?
All NHI devicesNHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHI
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NHI
120in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHI
No recall names NHI since 2007.
Adverse event reports per year · NHI
13in 2025
MAUDE reports naming product code NHI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 3 | 125 | 0 | 6 |
| 2022 | 3 | 120 | 0 | 8 |
| 2023 | 1 | — | 0 | 25 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061166: Deepwave Percutaneous Neuromodulation Pain Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061166
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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