Home / 510(k) Clearances / K894770

510(k) K894770

PERSONAL BACK WITH FIP KIT by Canadian Posture and Seating Centre, Inc. — Product Code KNN

K894770 is an FDA 510(k) premarket notification submitted by Canadian Posture and Seating Centre, Inc. for the device "PERSONAL BACK WITH FIP KIT". The FDA issued a decision of Substantially Equivalent on September 11, 1989. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Canadian Posture and Seating Centre, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1989
Date Received
July 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Components, Wheelchair
Device Class
Class I
Regulation Number
890.3920
Review Panel
PM
Submission Type

Other clearances by Canadian Posture and Seating Centre, Inc.

  • K894767 — CORNER SEAT (January 17, 1990)

Other clearances for product code KNN

  • K211919 — KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat (March 4, 2022)
  • K942308 — DYNASTY GC 12400 (GELL/CELL) (November 7, 1994)
  • K942310 — DYNASTY GC 12550 (GELL/CELL) (November 7, 1994)
  • K942311 — DYNASTY U1-33 AGM (November 7, 1994)
  • K942309 — DYNASTY U1-31 (GELL/CELL) (November 7, 1994)
  • K942312 — ALDEN LINEAGE WHEELCHAIR CUSHION (May 26, 1994)
  • K942260 — ALDEN WHEELCHAIR CUSHION (May 26, 1994)
  • K933051 — ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION (October 12, 1993)
  • K923942 — RHOMBO MEDICAL RHOMBO-FILL (March 24, 1993)
  • K925980 — PM (March 24, 1993)

FDA data resources