# DEN170018: NSS-2 System

- Pathway: De Novo (Direct)
- Applicant: Innovative Health Solutions (Ihs), Inc.
- Decided: Nov 15, 2017 after 243 days
- Product code: PZR (Percutaneous Nerve Stimulator For Opioid Withdrawal)
- Device class: 2
- Regulation: 21 CFR 882.5896
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K201873: Sparrow Therapy System (2021), 3 descendants of its own
- K173861: Drug Relief (2018), 2 descendants of its own
- K230796: Sparrow Ascent (2023), 1 descendant of its own
- K211971: Drug Relief v1 (2021), 1 descendant of its own
- K251246: Sparrow Ascent (2025), 0 descendants of its own

## Indications for use
The NSS-2 System is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination.

Source page: https://510kreport.com/device/DEN170018
Methodology: https://510kreport.com/methodology