Home / 510(k) Clearances / K930735

510(k) K930735

LORDEX LUMBAR EXTENSION MACHINE by Lordex, Inc. — Product Code ISD

K930735 is an FDA 510(k) premarket notification submitted by Lordex, Inc. for the device "LORDEX LUMBAR EXTENSION MACHINE". The FDA issued a decision of Substantially Equivalent on September 29, 1994. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1994
Date Received
February 11, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Measuring
Device Class
Class II
Regulation Number
890.5360
Review Panel
PM
Submission Type

Other clearances for product code ISD

  • K202979 — MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Do (December 21, 2020)
  • K183296 — REAL Immersive System (March 18, 2019)
  • K143512 — ActiSpec Activity Monitor (August 26, 2015)
  • K112121 — ERGOSELECT/GE (October 31, 2012)
  • K080545 — ACTITRAINER (July 24, 2008)
  • K053078 — ERGOSELECT 100 K/P, ERGOSELECT 200 K/P (April 27, 2006)
  • K990866 — QUINTON MEDTRACK CR PLUS TREADMILL (April 29, 1999)
  • K990813 — REHCOR (April 12, 1999)
  • K962855 — ULE-2, MULE-2, HAND ACCESSORY KIT (December 11, 1996)
  • K952163 — DAVID BACK CLINIC SYSTEM (August 12, 1996)

FDA data resources