KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat

FDA 510(k) K211919 · Kinetic Innovative Seating System, LLC

Substantially Equivalent

510(k) numberK211919

Submission

Device name
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
Applicant
Kinetic Innovative Seating System, LLC
Branford, CT, US
Received
June 21, 2021
Decision date
March 4, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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
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
K923364Tilt Adjustable Sliding Back Recline Seating SystKNN · Traditional Labac Systems, Inc.03/22/1993SE

Questions and answers

When was KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat cleared by the FDA?

KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat (K211919) received a 510(k) decision of Substantially Equivalent on March 4, 2022, 256 days after the submission was received.

What is the product code of K211919?

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