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510(k) K855181

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

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.

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

Other clearances for product code KNN

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  • K942311 — DYNASTY U1-33 AGM (November 7, 1994)
  • K942310 — DYNASTY GC 12550 (GELL/CELL) (November 7, 1994)
  • K942309 — DYNASTY U1-31 (GELL/CELL) (November 7, 1994)
  • K942308 — DYNASTY GC 12400 (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)
  • K925980 — PM (March 24, 1993)
  • K923942 — RHOMBO MEDICAL RHOMBO-FILL (March 24, 1993)