Clearance Summary
STIMUTRON MODEL 100 received FDA 510(k) clearance under submission number K865054, sponsored by The Austin-Lenick Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1987-02-26.
- Submission: K865054
- Applicant / Sponsor: The Austin-Lenick Co.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1987-02-26
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.