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510(k) K895740

SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART by Lumex, Inc. — Product Code FPO

K895740 is an FDA 510(k) premarket notification submitted by Lumex, Inc. for the device "SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART". The FDA issued a decision of Substantially Equivalent on February 22, 1990. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Lumex, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1990
Date Received
September 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stretcher, Wheeled
Device Class
Class II
Regulation Number
880.6910
Review Panel
HO
Submission Type

Other clearances by Lumex, Inc.

  • K963674 — LUMEX AIR (January 10, 1997)
  • K962123 — AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM (July 18, 1996)
  • K953675 — ALTADYNE (September 28, 1995)
  • K945175 — MECHANICAL WHEELCHAIR 890.3850 (May 12, 1995)
  • K945257 — 577ES (ERGOSENSE) (April 26, 1995)
  • K944574 — LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI) (October 17, 1994)
  • K923977 — AKROTECH 4000 (February 12, 1993)

Other clearances for product code FPO

  • K113598 — POWER-LOAD COT FASTENER SYSTEM (December 20, 2011)
  • K072598 — IRSG I-MOVER FOR BEDS (April 14, 2008)
  • K972528 — DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759) (July 28, 1997)
  • K955766 — ADULT-PEDIATRIC TRANSPORT SYSTEM (August 7, 1996)
  • K962181 — HARE MODEL 2000 EZ LOADER MODEL 95555 (August 1, 1996)
  • K961437 — WHEELED STRETCHER (June 3, 1996)
  • K952447 — HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER (November 22, 1995)
  • K946101 — EMERGENCY/ACCIDENT TROLLEY 550 (February 7, 1995)
  • K945431 — MODEL 792 CONVERGE, MODEL 793 VISION 2000 (January 25, 1995)
  • K943969 — MODEL 578 MOBILE SURGICAL STRETCHER (January 25, 1995)

FDA data resources