# K241365: Pixie Pulse (SM9068)

- Pathway: 510(k) (Traditional)
- Applicant: Pixie Cup, LLC
- Decided: Aug 12, 2024 after 90 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Pixie Pulse is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. The Pixie Pulse is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medications.

Source page: https://510kreport.com/device/K241365
Methodology: https://510kreport.com/methodology