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510(k) K110671

WINCO STRETCHAIR by Winco Mfg., LLC — Product Code INK

K110671 is an FDA 510(k) premarket notification submitted by Winco Mfg., LLC for the device "WINCO STRETCHAIR". The FDA issued a decision of Substantially Equivalent on April 22, 2011. The device falls under product code INK (Stretcher, Wheeled, Powered), a Class II device regulated under 21 CFR 890.3690.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2011
Date Received
March 9, 2011
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 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)
  • K102236 — HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P (November 18, 2010)
  • 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