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510(k) K915629

CUSHION, WHELCHAR AND FLOTATION by Invacare Corp. — Product Code KNN

K915629 is an FDA 510(k) premarket notification submitted by Invacare Corp. for the device "CUSHION, WHELCHAR AND FLOTATION". The FDA issued a decision of Substantially Equivalent on January 9, 1992. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Invacare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1992
Date Received
December 17, 1991
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 by Invacare Corp.

  • K071928 — THE INVACARE FLYER, MODEL IPC 100 (December 12, 2007)
  • K070321 — TWILIGHT FULL FACE MASK (April 30, 2007)
  • K062402 — EASYSTAND EVOLV (September 21, 2006)
  • K061874 — INVACARE'S TWILIGHT II NASAL MASKS (September 5, 2006)
  • K033819 — INVACARE 3G TARSYS (June 4, 2004)
  • K031176 — INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 (March 25, 2004)
  • K031064 — INVACARE POLARIS EX CPAP, MODEL ISP3000 (March 12, 2004)
  • K030814 — INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3 (March 20, 2003)
  • K022642 — TWLIGHT, MODEL ISP 9600 (February 11, 2003)
  • K023589 — STORM TDX POWER WHEELCHAIR (November 19, 2002)

Other clearances for product code KNN

  • K211919 — KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat (March 4, 2022)
  • K942311 — DYNASTY U1-33 AGM (November 7, 1994)
  • K942310 — DYNASTY GC 12550 (GELL/CELL) (November 7, 1994)
  • K942308 — DYNASTY GC 12400 (GELL/CELL) (November 7, 1994)
  • K942309 — DYNASTY U1-31 (GELL/CELL) (November 7, 1994)
  • K942260 — ALDEN WHEELCHAIR CUSHION (May 26, 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)

FDA data resources