Alden Lineage Wheelchair Cushion

FDA 510(k) K942312 · Lewis W. Ward

Substantially Equivalent

510(k) numberK942312

Submission

Device name
Alden Lineage Wheelchair Cushion
Applicant
Lewis W. Ward
Boulder, CO, US
Received
May 13, 1994
Decision date
May 26, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KNN – Components, Wheelchair
Device class
Class I (low risk)
Regulation
21 CFR 890.3920
Specialty
Physical Medicine

Other 510(k)s with product code KNN

510(k)DeviceApplicantDecision
K211919KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKNN · Traditional Kinetic Innovative Seating System, LLC03/04/2022SE
K942311Dynasty U1-33 AgmKNN · Traditional Foley & Lardner11/07/1994SE
K942310Dynasty GC 12550 (Gell/Cell)KNN · Traditional Foley & Lardner11/07/1994SE
K942309Dynasty U1-31 (Gell/Cell)KNN · Traditional Foley & Lardner11/07/1994SE
K942308Dynasty GC 12400 (Gell/Cell)KNN · Traditional Foley & Lardner11/07/1994SE
K942260Alden Wheelchair CushionKNN · Traditional Ward and Assoc.05/26/1994SE
K933051Zero Gravity Wheelchair Components, ModificationKNN · Traditional General Components Intl., Inc.10/12/1993SE
K925980PMKNN · Traditional Pathfinder Intl. Corp.03/24/1993SE
K923942Rhombo Medical Rhombo-FillKNN · Traditional International Medical Products, Inc.03/24/1993SE
K923364Tilt Adjustable Sliding Back Recline Seating SystKNN · Traditional Labac Systems, Inc.03/22/1993SE

Questions and answers

When was Alden Lineage Wheelchair Cushion cleared by the FDA?

Alden Lineage Wheelchair Cushion (K942312) received a 510(k) decision of Substantially Equivalent on May 26, 1994, 13 days after the submission was received.

What is the product code of K942312?

The FDA product code is KNN – Components, Wheelchair, a Class I (low risk) device regulated under 21 CFR 890.3920.