510(k) · Cleared
ClearedBiowaveHOME Neuromodulation Pain Therapy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biowave Corporation · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Sep 25, 2015 after a 29-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 12 later devices descend from it.
- Decided
- Sep 25, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
12 later devices descend from it, 2 citing it directly.
- This deviceK152437 BiowaveHOME Neuromodulation Pain Therapy DeviceBiowave Corporation · 2015
- 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
- Descendant · 5 generations on · 1 of its ownK213188 Primary ReliefDyansys, Inc. · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- 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
- K213188Primary ReliefDyansys, Inc. · 2022 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K152437 | BiowaveHOME Neuromodulation Pain Therapy Device | Biowave Corporation | 2015 | — |
| +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 | — |
| +5 | K213188 | Primary Relief | Dyansys, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 4 | 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 GZJ? 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 GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K121478 | FDA’s K121478 is Nuk Expressivetm Double Electric Breast Pump Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2013 |
What descends from it? (12)
See all 122 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?
- Of its descendants, K161154 (Spr Therapeutics, LLC, 2016) has gone furthest, with 9 descendants of its own.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, 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 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The BiowaveHOME Neuromodulation Pain Therapy Device is indicated for:
• Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain
• Symptomatic relief of acute pain
• Symptomatic relief of post-operative pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152437 · printed Nov 4, 2026
Cite this page
510(k) Report. “K152437: BiowaveHOME 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/K152437
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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