Clearance Summary
ULTRA-LITE PREMIER received FDA 510(k) clearance under submission number K841830, 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 1984-05-14.
- Submission: K841830
- Applicant / Sponsor: Everest & Jennings, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 1984-05-14
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.