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510(k) K844239

NEC-KRADLE BY VENCOR by Vencor — Product Code HST

K844239 is an FDA 510(k) premarket notification submitted by Vencor for the device "NEC-KRADLE BY VENCOR". The FDA issued a decision of Substantially Equivalent on November 19, 1984. The device falls under product code HST (Apparatus, Traction, Non-Powered), a Class I device regulated under 21 CFR 888.5850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1984
Date Received
November 1, 1984
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 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