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510(k) K152056

Winco Model S550 Stretchair by Winco Manufacturing, LLC — Product Code INK

K152056 is an FDA 510(k) premarket notification submitted by Winco Manufacturing, LLC for the device "Winco Model S550 Stretchair". The FDA issued a decision of Substantially Equivalent on April 11, 2016. 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 11, 2016
Date Received
July 24, 2015
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

  • K140095 — PRIME ZOOM STRETCHER (May 20, 2014)
  • K112502 — PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 (September 19, 2011)
  • K110671 — WINCO STRETCHAIR (April 22, 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