Clearance Summary
EZ ON SAFETY PONCHO received FDA 510(k) clearance under submission number K801489, sponsored by Skil-Care 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 1980-07-14.
- Submission: K801489
- Applicant / Sponsor: Skil-Care Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3910
- Decision date: 1980-07-14
Classification & Regulation
This clearance is catalogued under FDA product code KNO and 21 CFR 890.3910, within the Physical Medicine review panel as a Class I device.