Clearance Summary
SOLOLIFT - PATIENT TRANSFER STRETCHER received FDA 510(k) clearance under submission number K871475, sponsored by Adel Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1987-05-11.
- Submission: K871475
- Applicant / Sponsor: Adel Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6785
- Decision date: 1987-05-11
Classification & Regulation
This clearance is catalogued under FDA product code FMR and 21 CFR 880.6785, within the General Hospital review panel as a Class I device.