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510(k) K102236

HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P by D.T. Davis Enterprises Ltd. T/A Hovertech Int'L — Product Code INK

K102236 is an FDA 510(k) premarket notification submitted by D.T. Davis Enterprises Ltd. T/A Hovertech Int'L for the device "HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P". The FDA issued a decision of Substantially Equivalent on November 18, 2010. The device falls under product code INK (Stretcher, Wheeled, Powered), a Class II device regulated under 21 CFR 890.3690. D.T. Davis Enterprises Ltd. T/A Hovertech Int'L has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2010
Date Received
August 9, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stretcher, Wheeled, Powered
Device Class
Class II
Regulation Number
890.3690
Review Panel
PM
Submission Type

Other clearances by D.T. Davis Enterprises Ltd. T/A Hovertech Int'L

  • K121287 — HT-WEDGE (October 3, 2012)

Other clearances for product code INK

  • K152056 — Winco Model S550 Stretchair (April 11, 2016)
  • K140095 — PRIME ZOOM STRETCHER (May 20, 2014)
  • K112502 — PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 (September 19, 2011)
  • K110671 — WINCO STRETCHAIR (April 22, 2011)
  • K091043 — POWER DRIVE CHAIR, MODEL: TMM6 (May 11, 2009)
  • K051861 — THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777 (September 28, 2005)
  • K041924 — HAUSTED POWERTRAN SERIES STRETCHER (September 9, 2004)
  • K022309 — STRYKER POWERED WHEELED STRETCHER (November 8, 2002)
  • K912175 — ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE (June 7, 1991)
  • K844711 — MODELS 134, 135 & 136 TRANSFER CART/TABLE (March 5, 1985)

FDA data resources