Clearance Summary
FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000 received FDA 510(k) clearance under submission number K863753, sponsored by Foundations Plus, 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 1986-10-30.
- Submission: K863753
- Applicant / Sponsor: Foundations Plus, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5240
- Decision date: 1986-10-30
Classification & Regulation
This clearance is catalogued under FDA product code KGX and 21 CFR 880.5240, within the General Hospital review panel as a Class I device.