# K221231: Drug Relief v1

- Pathway: 510(k) (Special)
- Applicant: Dyansys, Inc.
- Decided: Jun 6, 2022 after 38 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
Longest line of descent: 3 generations back to DEN170018 (2017). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211971: Drug Relief v1, Dyansys, Inc. (2021) Summary page 4.

## Indications for use
The Drug Reliefv1 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/K221231
Methodology: https://510kreport.com/methodology