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510(k) K211919

KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat by Kinetic Innovative Seating System, LLC — Product Code KNN

K211919 is an FDA 510(k) premarket notification submitted by Kinetic Innovative Seating System, LLC for the device "KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat". The FDA issued a decision of Substantially Equivalent on March 4, 2022. 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
March 4, 2022
Date Received
June 21, 2021
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

  • K942311 — DYNASTY U1-33 AGM (November 7, 1994)
  • K942308 — DYNASTY GC 12400 (GELL/CELL) (November 7, 1994)
  • K942310 — DYNASTY GC 12550 (GELL/CELL) (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)
  • K923364 — TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST (March 22, 1993)

FDA data resources