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510(k) K864765

MODEL 668, TRACTION SPLINT, ADULT by Ferno-Washington, Inc. — Product Code HST

K864765 is an FDA 510(k) premarket notification submitted by Ferno-Washington, Inc. for the device "MODEL 668, TRACTION SPLINT, ADULT". The FDA issued a decision of Substantially Equivalent on December 17, 1986. The device falls under product code HST (Apparatus, Traction, Non-Powered), a Class I device regulated under 21 CFR 888.5850. Ferno-Washington, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1986
Date Received
December 5, 1986
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 Ferno-Washington, Inc.

  • K980033 — FERNO HEALTHCARE RECLINE-A-BATH 2 (April 21, 1998)
  • K932417 — FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT (September 9, 1993)
  • K864269 — MODEL 35-B ALL LEVEL COT (November 13, 1986)
  • K862441 — EZ LOAD MODEL 30, ALL LEVEL COT (September 12, 1986)

Other clearances for product code HST

  • K162702 — Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Dec (December 30, 2016)
  • 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)
  • K862874 — THE TOWERED 90/90 UNIT (August 7, 1986)
  • K860037 — SUSPENDER ORTHOPEDIC SUSPENSION DEVICE (January 21, 1986)
  • K855179 — TRANSFER-TRAX (TM) SPLINT TRACTION (January 21, 1986)

FDA data resources