510(k) · Cleared
ClearedFirst Relief
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dyansys, Inc. · NHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Cleared on Dec 20, 2021 as substantially equivalent to K202660 (Spr Therapeutics, Inc., 2021) and 3 other predicates after a 103-day review. Its family tree reaches back 10 generations to 1988.
- Decided
- Dec 20, 2021
- Review
- 103 days
- Class
- Class II
- Product code
- NHI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K881114 (1988). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK881114 Empi Model 989, TensEmpi · 1988
- 6 generations between
- 3 generations backK170902 Sprint System, Single Procedure Kit, Sprint System with Pad II…Spr Therapeutics, LLC · 2017
- 2 generations backK181422 SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT…Spr Therapeutics, Inc. · 2018
- 1 generation backK202660 SPRINT PNS SystemSpr Therapeutics, Inc. · 2021
- This deviceK212859 First ReliefDyansys, Inc. · 2021
Show all 10 generations
- Root · 10 generations backK881114 Empi Model 989, TensEmpi · 1988
- 9 generations backK970203 Epix VTEmpi · 1997
- 8 generations backK011702 Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100…Vertis Neuroscience, Inc. · 2001
- 7 generations backK022241 Vertis PNT Control Unit, Model CU 100; Vertis PNT…Vertis Neuroscience, Inc. · 2002
- 6 generations backK061166 Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006
- 5 generations backK072123 Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008
- 4 generations backK161154 Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator…Spr Therapeutics, LLC · 2016
- 3 generations backK170902 Sprint System, Single Procedure Kit, Sprint System with Pad II…Spr Therapeutics, LLC · 2017
- 2 generations backK181422 SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT…Spr Therapeutics, Inc. · 2018
- 1 generation backK202660 SPRINT PNS SystemSpr Therapeutics, Inc. · 2021
- This deviceK212859 First ReliefDyansys, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −9 | K970203 | Epix VT | Empi | 1997 | — |
| −8 | K011702 | Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx | Vertis Neuroscience, Inc. | 2001 | — |
| −7 | K022241 | Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG… | Vertis Neuroscience, Inc. | 2002 | — |
| −6 | K061166 | Deepwave Percutaneous Neuromodulation Pain Therapy System | Biowave Corporation | 2006 | — |
| −5 | K072123 | Homewave Neuromodulations Pain Therapy Device | Biowave Corporation | 2008 | — |
| −4 | K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and… | Spr Therapeutics, LLC | 2016 | — |
| −3 | K170902 | Sprint System, Single Procedure Kit, Sprint System with Pad II, Single… | Spr Therapeutics, LLC | 2017 | — |
| −2 | K181422 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve… | Spr Therapeutics, Inc. | 2018 | — |
| −1 | K202660 | SPRINT PNS System | Spr Therapeutics, Inc. | 2021 | — |
| 0 (this device) | K212859 | First Relief | Dyansys, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2015 | 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? (4)
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 |
|---|---|---|---|
| * | K202660 | SPRINT PNS SystemSummary page 4…ation (PENS) devices (21 CFR 882.5890) Device Class: Class II Product Code: NHI III. PREDICATE DEVICE Model Name: SPRINT PNS System (K202660, K181422, K170902, K161154) Manufacturer: SPR Therapeutics, Inc. First Relief v1 (K202940) manufactured by our company has been… | 2021 |
| * | K181422 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation…Summary page 4…NS) devices (21 CFR 882.5890) Device Class: Class II Product Code: NHI III. PREDICATE DEVICE Model Name: SPRINT PNS System (K202660, K181422, K170902, K161154) Manufacturer: SPR Therapeutics, Inc. First Relief v1 (K202940) manufactured by our company has been used as r… | 2018 |
| * | K170902 | Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit…Summary page 4…es (21 CFR 882.5890) Device Class: Class II Product Code: NHI III. PREDICATE DEVICE Model Name: SPRINT PNS System (K202660, K181422, K170902, K161154) Manufacturer: SPR Therapeutics, Inc. First Relief v1 (K202940) manufactured by our company has been used as reference… | 2017 |
| * | K161154 | Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…Summary page 4…(21 CFR 882.5890) Device Class: Class II Product Code: NHI III. PREDICATE DEVICE Model Name: SPRINT PNS System (K202660, K181422, K170902, K161154) Manufacturer: SPR Therapeutics, Inc. First Relief v1 (K202940) manufactured by our company has been used as reference device in… | 2016 |
| † | K202940 | First Relief v1 | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- None of the 24 ancestors has a recall.
- 2 other devices also cite its predicate K202660.
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. 2021, this device’s year, is highlighted.
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 First Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for multiple treatments up to 56 days for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212859 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212859: First Relief.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212859
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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