Clearance Summary
ABDUCTION PILLOW received FDA 510(k) clearance under submission number K830243, sponsored by Warm & Form, Orthopedic Materials. 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 1983-03-08.
- Submission: K830243
- Applicant / Sponsor: Warm & Form, Orthopedic Materials
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3665
- Decision date: 1983-03-08
Classification & Regulation
This clearance is catalogued under FDA product code IOZ and 21 CFR 890.3665, within the Physical Medicine review panel as a Class I device.