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510(k) K813017

NECKTRAC by Lossing Orthopedic, Inc. — Product Code HST

K813017 is an FDA 510(k) premarket notification submitted by Lossing Orthopedic, Inc. for the device "NECKTRAC". The FDA issued a decision of Substantially Equivalent on November 25, 1981. The device falls under product code HST (Apparatus, Traction, Non-Powered), a Class I device regulated under 21 CFR 888.5850. Lossing Orthopedic, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 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 Lossing Orthopedic, Inc.

  • K900475 — DISTRAC(TM) TABLE (May 24, 1990)
  • K864152 — BACK SAVER LIFT BELT/WHEELCHAIR TRANSFER DEVICE (February 5, 1987)
  • K862874 — THE TOWERED 90/90 UNIT (August 7, 1986)
  • K843581 — PROM NAID (December 11, 1984)
  • K840551 — MOBILIZER (March 23, 1984)
  • K823236 — BACK ON TRACK INVERSION THERAPY & EXER (January 21, 1983)
  • K802555 — COTTRELL 90/90 BACKTRAC (October 31, 1980)

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