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510(k) K240843

GENESIS (MS-P02-GEN) by Climbing Steps, Inc. — Product Code ILK

K240843 is an FDA 510(k) premarket notification submitted by Climbing Steps, Inc. for the device "GENESIS (MS-P02-GEN)". The FDA issued a decision of Substantially Equivalent on October 7, 2024. The device falls under product code ILK (Transport, Patient, Powered), a Class II device regulated under 21 CFR 890.5150.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2024
Date Received
March 27, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transport, Patient, Powered
Device Class
Class II
Regulation Number
890.5150
Review Panel
PM
Submission Type

A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.

Other clearances for product code ILK

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  • K130864 — C-MAX+ (PLUS) (February 6, 2014)
  • K121560 — LEVANT, HOMEGLIDE (November 1, 2012)
  • K121561 — FLOW2, SWING (October 26, 2012)
  • K113308 — BRUNO ELAN STAIRWAY ELEVATOR (February 1, 2012)
  • K111858 — LIFTKAR PT (November 4, 2011)
  • K103122 — C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION (December 30, 2010)
  • K093946 — HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 (March 22, 2010)
  • K091858 — PINNACLE STAIR WAY LIFT (July 1, 2009)
  • K073110 — MERITS E600 SERIES STAIR LIFT (February 6, 2008)

FDA data resources