Clearance Summary
STIMULATOR, FACIAL-MODELS SF-100 & 200 received FDA 510(k) clearance under submission number K811502, sponsored by Rcx-Western, Inc.. 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 1981-07-24.
- Submission: K811502
- Applicant / Sponsor: Rcx-Western, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1981-07-24
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.