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510(k) K923977

AKROTECH 4000 by Lumex, Inc. — Product Code IOQ

K923977 is an FDA 510(k) premarket notification submitted by Lumex, Inc. for the device "AKROTECH 4000". The FDA issued a decision of Substantially Equivalent on February 12, 1993. The device falls under product code IOQ (Bed, Flotation Therapy, Powered), a Class II device regulated under 21 CFR 890.5170. Lumex, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1993
Date Received
August 7, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Flotation Therapy, Powered
Device Class
Class II
Regulation Number
890.5170
Review Panel
PM
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)
  • K895740 — SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART (February 22, 1990)

Other clearances for product code IOQ

  • K143414 — Hill-Rom Wireless Connectivity Module (March 10, 2015)
  • K122473 — TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE (June 3, 2013)
  • K973624 — NURSE'S AID PATIENT ROTATION SYSTEM (January 21, 1998)
  • K970364 — AIRTEC2 LOW AIR LOSS THERAPY BED (November 17, 1997)
  • K970363 — HYDROTEC LOW AIR LOSS THERAPY BED (November 17, 1997)
  • K970636 — TOTALCARE., MODULAR THERAPY SYSTEM (MTS) (August 26, 1997)
  • K964873 — SILKAIR LOW AIRLOSS THERAPY (July 3, 1997)
  • K970295 — FLEXICAIR EXLIPSE PLUS (May 16, 1997)
  • K943433 — TOTAL CONTACT SEAT RIPPLE SYSTEM (July 31, 1995)
  • K951001 — FLEXICAIR EXLIPSE (June 27, 1995)

FDA data resources