Clearance Summary
GEL-T CUSHION received FDA 510(k) clearance under submission number K960189, 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 1996-02-07.
- Submission: K960189
- 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: 1996-02-07
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.