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510(k) Data Aggregation
K Number
K241365Device Name
Pixie Pulse (SM9068)
Manufacturer
Date Cleared
2024-08-12
(90 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Pixie Cup LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
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