# K161154: Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs

- Pathway: 510(k) (Traditional)
- Applicant: Spr Therapeutics, LLC
- Decided: Jul 23, 2016 after 89 days
- Product code: NHI (Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief)
- 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: 6 generations back to K881114 (1988). 20 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052289: Deepwave Neuromodulation Pain Therapy Device, Biowave Corporation (2005) Summary page 4.
- K061166: Deepwave Percutaneous Neuromodulation Pain Therapy System, Biowave Corporation (2006) Summary page 4.
- K072123: Homewave Neuromodulations Pain Therapy Device, Biowave Corporation (2008) Summary page 4.
- K152437: BiowaveHOME Neuromodulation Pain Therapy Device, Biowave Corporation (2015) Summary page 4.

## Most influential descendants
- 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
- K202660: SPRINT PNS System (2021), 5 descendants of its own
- K213188: Primary Relief (2022), 1 descendant of its own
- K211801: SPRINT PNS System (2021), 1 descendant of its own

## Indications for use
The Smartpatch Peripheral Nerve Stimulation (PNS) System is indicated for up to 30 days in the back and/or extremities 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. The Smartpatch PNS System is not intended to treat pain in the craniofacial region.

Source page: https://510kreport.com/device/K161154
Methodology: https://510kreport.com/methodology