K241365
- 510(k) number
- K241365
- Device name
- Pixie Pulse (SM9068)
- Applicant
- Pixie Cup, LLC MO · US
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2024-08-12
- Date received
- 2024-05-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K241365
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.