Clearance Summary
SERENA WHEELCHAIR CUSHIONS received FDA 510(k) clearance under submission number K915368, sponsored by A & C Medical Supply. 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 1991-12-20.
- Submission: K915368
- Applicant / Sponsor: A & C Medical Supply
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3920
- Decision date: 1991-12-20
Classification & Regulation
This clearance is catalogued under FDA product code KNN and 21 CFR 890.3920, within the Physical Medicine review panel as a Class I device.