Clearance Summary
SAFETY PONCHO/SHOULDER STRAP PONCHO received FDA 510(k) clearance under submission number K963461, 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 1996-10-11.
- Submission: K963461
- Applicant / Sponsor: Skil-Care Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3910
- Decision date: 1996-10-11
Classification & Regulation
This clearance is catalogued under FDA product code KID and 21 CFR 890.3910, within the Physical Medicine review panel as a Class I device.