Clearance Summary
TUBMATE received FDA 510(k) clearance under submission number K811301, sponsored by American Stair-Glide 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 1981-05-27.
- Submission: K811301
- Applicant / Sponsor: American Stair-Glide Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5050
- Decision date: 1981-05-27
Classification & Regulation
This clearance is catalogued under FDA product code ILS and 21 CFR 890.5050, within the Physical Medicine review panel as a Class I device.