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510(k) K112121

ERGOSELECT/GE by Ergoline GmbH — Product Code ISD

K112121 is an FDA 510(k) premarket notification submitted by Ergoline GmbH for the device "ERGOSELECT/GE". The FDA issued a decision of Substantially Equivalent on October 31, 2012. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360. Ergoline GmbH has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2012
Date Received
July 25, 2011
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 by Ergoline GmbH

  • K212883 — ers2 - ergoline Rehabilitation System (July 15, 2022)
  • K053078 — ERGOSELECT 100 K/P, ERGOSELECT 200 K/P (April 27, 2006)

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)
  • 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)
  • K941033 — PHYSIO HAB (February 27, 1995)

FDA data resources