Clearance Summary
STOUTE'S ASSIST-SEAT WHEELCHAIR COMPONENT received FDA 510(k) clearance under submission number K882253, sponsored by Stoute'S "Assist-Seat" Corp.. 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 1988-06-27.
- Submission: K882253
- Applicant / Sponsor: Stoute'S "Assist-Seat" Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3920
- Decision date: 1988-06-27
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.