K233098
- 510(k) number
- K233098
- Device name
- MYOTouch Muscle Stimulator
- Applicant
- Sunmed, LLC MI · US
- Product code
- IPF — Stimulator, Muscle, Powered
- Decision date
- 2024-08-02
- Date received
- 2023-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
510(k) Summary (official FDA PDF): K233098.pdf
Official FDA record: K233098
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.