Clearance Summary
ROTO REST; TRAUMA AND INTENSIVE CARE BED received FDA 510(k) clearance under submission number K905113, sponsored by Ethos Medical Products , Ltd.. 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 1990-11-26.
- Submission: K905113
- Applicant / Sponsor: Ethos Medical Products , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5225
- Decision date: 1990-11-26
Classification & Regulation
This clearance is catalogued under FDA product code IKZ and 21 CFR 890.5225, within the Physical Medicine review panel as a Class II device.