K243334
- 510(k) number
- K243334
- Device name
- Nooro Body & Foot Stimulator (SM9141, SM9142)
- Applicant
- Xf Agencija Limited CN
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2024-11-22
- Date received
- 2024-10-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Neurology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K243334
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.