Clearance Summary
CRS ULTRALITE PREMIER received FDA 510(k) clearance under submission number K851257, sponsored by Everest & Jennings, 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 1985-06-28.
- Submission: K851257
- Applicant / Sponsor: Everest & Jennings, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 1985-06-28
Classification & Regulation
This clearance is catalogued under FDA product code IOR and 21 CFR 890.3850, within the Physical Medicine review panel as a Class I device.