Clearance Summary
HOYER ONE-TOUCH POWER LIFTER received FDA 510(k) clearance under submission number K860837, sponsored by Ted Hoyer & Co., Inc.. 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 1986-03-27.
- Submission: K860837
- Applicant / Sponsor: Ted Hoyer & Co., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5510
- Decision date: 1986-03-27
Classification & Regulation
This clearance is catalogued under FDA product code FSA and 21 CFR 880.5510, within the General Hospital review panel as a Class I device.