Clearance Summary
COVER, LIMB received FDA 510(k) clearance under submission number K801627, sponsored by The Owenby Co.. 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 1980-07-28.
- Submission: K801627
- Applicant / Sponsor: The Owenby Co.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3025
- Decision date: 1980-07-28
Classification & Regulation
This clearance is catalogued under FDA product code IPM and 21 CFR 890.3025, within the Physical Medicine review panel as a Class I device.