Stoute's Assist-Seat Wheelchair Component

FDA 510(k) K882253 · Stoute'S "Assist-Seat" Corp.

Substantially Equivalent

510(k) numberK882253

Submission

Device name
Stoute's Assist-Seat Wheelchair Component
Applicant
Stoute'S "Assist-Seat" Corp.
Bronx, NY, US
Received
May 31, 1988
Decision date
June 27, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K942312Alden Lineage Wheelchair CushionKNN · Traditional Lewis W. Ward05/26/1994SE
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

Questions and answers

When was Stoute's Assist-Seat Wheelchair Component cleared by the FDA?

Stoute's Assist-Seat Wheelchair Component (K882253) received a 510(k) decision of Substantially Equivalent on June 27, 1988, 27 days after the submission was received.

What is the product code of K882253?

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