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K Number
K241365
Device Name
Pixie Pulse (SM9068)
Manufacturer
Pixie Cup LLC
Date Cleared
2024-08-12

(90 days)

Product Code
NUH,DAT
Regulation Number
882.5890
Type
Traditional
Panel
Neurology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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, wast, 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 dysmenorthea (menstrual cramps) when used with over-the-counter pain medications.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the Pixie Pulse (SM9068) Transcutaneous Electrical Nerve Stimulator, outlining its approved indications for use and regulatory compliance. It does not include details on performance studies, sample sizes, ground truth establishment, or expert involvement.

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).