Clearance Summary
POWERED TREADMILL (30/ST) received FDA 510(k) clearance under submission number K761041, sponsored by Physio-Control 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 1976-12-09.
- Submission: K761041
- Applicant / Sponsor: Physio-Control Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5380
- Decision date: 1976-12-09
Classification & Regulation
This clearance is catalogued under FDA product code IOL and 21 CFR 890.5380, within the Physical Medicine review panel as a Class I device.