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510(k) K942260

ALDEN WHEELCHAIR CUSHION by Ward and Assoc. — Product Code KNN

K942260 is an FDA 510(k) premarket notification submitted by Ward and Assoc. for the device "ALDEN WHEELCHAIR CUSHION". The FDA issued a decision of Substantially Equivalent on May 26, 1994. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1994
Date Received
May 9, 1994
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 for product code KNN

  • K211919 — KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat (March 4, 2022)
  • 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)
  • K942308 — DYNASTY GC 12400 (GELL/CELL) (November 7, 1994)
  • K942312 — ALDEN LINEAGE 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)
  • K923364 — TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST (March 22, 1993)

FDA data resources