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510(k) K855181

COMFORTEX WHEELCHAIR CUSHION by Comfortex, Inc. — Product Code KNN

K855181 is an FDA 510(k) premarket notification submitted by Comfortex, Inc. for the device "COMFORTEX WHEELCHAIR CUSHION". The FDA issued a decision of Substantially Equivalent on January 13, 1986. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Comfortex, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1986
Date Received
December 26, 1985
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 Comfortex, Inc.

  • K860037 — SUSPENDER ORTHOPEDIC SUSPENSION DEVICE (January 21, 1986)
  • K855179 — TRANSFER-TRAX (TM) SPLINT TRACTION (January 21, 1986)
  • K854270 — MURPHY ADJUSTABLE SPLINT (December 9, 1985)

Other clearances for product code KNN

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

FDA data resources