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510(k) K113065

RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS by Bella Elevator, LLC — Product Code ING

K113065 is an FDA 510(k) premarket notification submitted by Bella Elevator, LLC for the device "RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS". The FDA issued a decision of Substantially Equivalent on February 22, 2012. The device falls under product code ING (Elevator, Wheelchair, Portable), a Class II device regulated under 21 CFR 890.3930.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2012
Date Received
October 14, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elevator, Wheelchair, Portable
Device Class
Class II
Regulation Number
890.3930
Review Panel
PM
Submission Type

A motorized lift device that is not permanently mounted in one location and that is intended for medical purposes to provide a means to move a person with impaired mobility, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).

Other clearances for product code ING

  • K110495 — LIFTKAR PT (May 20, 2011)
  • K102088 — JOURNEY INCLINED PLATFORM LIFT AND SUPRA CURVED INCLINE PLATFORM LIFT (October 20, 2010)
  • K091881 — RPL/CPL VERTICAL PLATFORM LIFTS (July 1, 2009)
  • K090856 — JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02) (May 27, 2009)
  • K073513 — MERITS E700 PORCE LIFT (January 14, 2008)
  • K061514 — BRUNO VERTICAL PLATFORM LIFT, MODEL VPL-3100 (July 13, 2006)
  • K033469 — GENESIS VERTICAL PLATFORM LIFT (January 7, 2004)
  • K024346 — THE MULTILIFT (March 4, 2003)
  • K020933 — GARAVENTA SUPER-TRAC TRE-52 (April 4, 2002)
  • K983526 — VERTICAL LIFT (December 11, 1998)

FDA data resources