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510(k) K791396

MEDI-TRAK PORTABLE TRACTION DEVICE by Medicorp, Inc. — Product Code HST

K791396 is an FDA 510(k) premarket notification submitted by Medicorp, Inc. for the device "MEDI-TRAK PORTABLE TRACTION DEVICE". The FDA issued a decision of Substantially Equivalent on August 16, 1979. The device falls under product code HST (Apparatus, Traction, Non-Powered), a Class I device regulated under 21 CFR 888.5850. Medicorp, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1979
Date Received
July 10, 1979
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 Medicorp, Inc.

  • K860026 — ULTRAMAX III, DIALYZER REPROCESSING DEVICE (March 14, 1986)
  • K844850 — MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT (April 2, 1985)
  • K832705 — ULTRAMAX (June 25, 1984)
  • K791164 — NEGATOVE PRESSURE CONVERTOR (October 4, 1979)

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)
  • 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)

FDA data resources