Clearance Summary
CUSTOMCARE SEATING SYSTEM received FDA 510(k) clearance under submission number K954117, sponsored by Span-America Medical Systems, 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 1995-10-13.
- Submission: K954117
- Applicant / Sponsor: Span-America Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3175
- Decision date: 1995-10-13
Classification & Regulation
This clearance is catalogued under FDA product code KIC and 21 CFR 890.3175, within the Physical Medicine review panel as a Class I device.