# K221425: Primary Relief

- Pathway: 510(k) (Traditional)
- Applicant: Dyansys, Inc.
- Decided: Sep 13, 2022 after 120 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: 11 generations back to K881114 (1988). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213188: Primary Relief, Dyansys, Inc. (2022) Summary page 4.

## Indications for use
The Primary Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for up to 3 days for symptomatic relief of post-operative pain following cesarean section delivery or up to 3 days adjunctive symptomatic relief of post-operative pain following cardiac surgery.

Source page: https://510kreport.com/device/K221425
Methodology: https://510kreport.com/methodology