Clearance Summary
ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS received FDA 510(k) clearance under submission number K923159, sponsored by Arjo-Century, Inc.. 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 1992-08-06.
- Submission: K923159
- Applicant / Sponsor: Arjo-Century, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5100
- Decision date: 1992-08-06
Classification & Regulation
This clearance is catalogued under FDA product code ILJ and 21 CFR 890.5100, within the Physical Medicine review panel as a Class II device.