510(k) K890653
K890653 is an FDA 510(k) premarket notification submitted by Clark Pillow Co., Inc. for the device "ULTIMA WHEELCHAIR CUSHION". The FDA issued a decision of Substantially Equivalent on February 28, 1989. The device falls under product code IMP (Cushion, Wheelchair), a Class I device regulated under 21 CFR 890.3920.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1989
- Date Received
- February 8, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cushion, Wheelchair
- Device Class
- Class I
- Regulation Number
- 890.3920
- Review Panel
- PM
- Submission Type