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510(k) K882091

STAIR VEYOR by Pride Health Care, Inc. — Product Code ILK

K882091 is an FDA 510(k) premarket notification submitted by Pride Health Care, Inc. for the device "STAIR VEYOR". The FDA issued a decision of Substantially Equivalent on May 26, 1988. The device falls under product code ILK (Transport, Patient, Powered), a Class II device regulated under 21 CFR 890.5150. Pride Health Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1988
Date Received
May 19, 1988
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 by Pride Health Care, Inc.

  • K945936 — JAZZY (May 28, 1996)
  • K944940 — EURO SC500 (February 12, 1996)
  • K953342 — TMR48 (September 8, 1995)
  • K944277 — DYNAMO (December 28, 1994)
  • K944939 — CELEBRITY XL SC445 (November 7, 1994)
  • K931231 — SIDEKICK II (May 5, 1994)
  • K926295 — LEGEND SC 300 (March 28, 1994)
  • K926296 — CELEBRITY SC400 (March 28, 1994)
  • K930952 — PRIDE LEGEND SC-340 (March 28, 1994)
  • K930953 — CELEBRITY SC440 (March 28, 1994)

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