# NHI: Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

- Device class: 2; regulation: 21 CFR 882.5890; FDA's rule: 510(k) required
- FDA decisions: 13
- 510(k) review time 2021–2025: median 120 days (middle half 97–125)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2001: 1
- 2002: 1
- 2006: 1
- 2016: 1
- 2017: 1
- 2018: 1
- 2021: 3
- 2022: 3
- 2023: 1

## Most-cited predicates
- K161154: Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs (2016), cited by 3
- K202660: SPRINT PNS System (2021), cited by 3
- K061166: Deepwave Percutaneous Neuromodulation Pain Therapy System (2006), cited by 3
- 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), cited by 2
- K181422: SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit (2018), cited by 2
- K213188: Primary Relief (2022), cited by 1
- K211801: SPRINT PNS System (2021), cited by 1
- K011702: Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx (2001), cited by 1
- K022241: Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXX (2002), cited by 1

Source page: https://510kreport.com/product-code/NHI
Data by year (CSV): https://510kreport.com/product-code/NHI.csv