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510(k) K855179

TRANSFER-TRAX (TM) SPLINT TRACTION by Comfortex, Inc. — Product Code HST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1986
Date Received
December 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Traction, Non-Powered
Device Class
Class I
Regulation Number
888.5850
Review Panel
NE
Submission Type

Other clearances by Comfortex, Inc.

  • K860037 — SUSPENDER ORTHOPEDIC SUSPENSION DEVICE (January 21, 1986)
  • K855181 — COMFORTEX WHEELCHAIR CUSHION (January 13, 1986)
  • K854270 — MURPHY ADJUSTABLE SPLINT (December 9, 1985)

Other clearances for product code HST

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  • K110858 — LO-BAK TRAX (August 2, 2011)
  • K984190 — BACK-ON-TRAC, MODEL 101BOT (March 15, 1999)
  • K872121 — K AND D HOME TRACT (August 12, 1987)
  • K870212 — ARTHROSCOPIC SHOULDER HOLDER (February 20, 1987)
  • K870125 — EXTREMITY ELEVATOR (February 4, 1987)
  • K870102 — TUPPER TROLLEY (February 3, 1987)
  • K864765 — MODEL 668, TRACTION SPLINT, ADULT (December 17, 1986)
  • K862874 — THE TOWERED 90/90 UNIT (August 7, 1986)
  • K860037 — SUSPENDER ORTHOPEDIC SUSPENSION DEVICE (January 21, 1986)