K241509
- 510(k) number
- K241509
- Device name
- TENS&EMS units (SM9109A, SM9109B)
- Applicant
- Plexus Yoga, LLC Dba Chirp UT · US
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2024-06-27
- Date received
- 2024-05-28
- 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: K241509
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.