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510(k) K033829

BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100 by Bruno Independent Living Aids, Inc. — Product Code ILK

K033829 is an FDA 510(k) premarket notification submitted by Bruno Independent Living Aids, Inc. for the device "BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100". The FDA issued a decision of Substantially Equivalent on December 29, 2003. The device falls under product code ILK (Transport, Patient, Powered), a Class II device regulated under 21 CFR 890.5150. Bruno Independent Living Aids, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2003
Date Received
December 9, 2003
Clearance Type
Special
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 by Bruno Independent Living Aids, Inc.

  • K113308 — BRUNO ELAN STAIRWAY ELEVATOR (February 1, 2012)
  • K061514 — BRUNO VERTICAL PLATFORM LIFT, MODEL VPL-3100 (July 13, 2006)
  • K033752 — BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540 (December 12, 2003)
  • K033438 — BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000 (November 20, 2003)
  • K022509 — BRUNO ELECTRA-RIDE, MODEL SRE-2700 (August 13, 2002)
  • K011227 — REGAL MOTOTRIZED 3 WHEELED VEHICLE (May 11, 2001)
  • K002205 — CARONY (August 10, 2000)
  • K991954 — THE BRUNO POWERBASE, MODEL PSB-2200 (November 2, 1999)
  • K970927 — BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM (August 26, 1997)
  • K921647 — REGAL MOTORIZIED 3 WHEELED VEHICLE (May 4, 1992)

Other clearances for product code ILK

  • K240843 — GENESIS (MS-P02-GEN) (October 7, 2024)
  • K222818 — Xpedition ™ Powered Stair Chair (625700000000) (January 24, 2023)
  • 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)

FDA data resources