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510(k) K813016

ZEE TRACTION SPLINT by Zee Medical Products Co., Inc. — Product Code HST

K813016 is an FDA 510(k) premarket notification submitted by Zee Medical Products Co., Inc. for the device "ZEE TRACTION SPLINT". The FDA issued a decision of Substantially Equivalent on November 24, 1981. The device falls under product code HST (Apparatus, Traction, Non-Powered), a Class I device regulated under 21 CFR 888.5850. Zee Medical Products Co., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1981
Date Received
October 27, 1981
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 Zee Medical Products Co., Inc.

  • K823501 — ZEE SPHYGMOMANOMETER (January 21, 1983)
  • K813156 — ULTRA-WIDE SAFETY SPECTACLE FRAME (December 14, 1981)
  • K812814 — ZEE SURGICAL INSTRUMENTS (November 6, 1981)
  • K812564 — ZEE LIFE SUPPORT AIR PANTS (October 23, 1981)
  • K812342 — ZEE EXTRICATION DEVICE (September 21, 1981)
  • K812284 — ZEE ELECTRODE-GEL (September 8, 1981)
  • K812022 — ZEE MANUAL RESUSCITATOR (July 31, 1981)

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