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510(k) K894154

METABOLIC SYSTEMS by Cybex — Product Code ISD

K894154 is an FDA 510(k) premarket notification submitted by Cybex for the device "METABOLIC SYSTEMS". The FDA issued a decision of Substantially Equivalent on October 24, 1989. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360. Cybex has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1989
Date Received
June 14, 1989
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 Cybex

  • K950095 — CYBEX 770 (June 21, 1995)
  • K905525 — CYBEX 6000 (February 14, 1991)
  • K881676 — LINEAR LIFT DEVICE (April 25, 1990)
  • K881681 — CYBEX BACK TESTING AND REHABILITATION SYSTEM (April 25, 1990)
  • K873599 — EDI 320 (October 16, 1987)
  • K872911 — CYBEX 340 (September 24, 1987)
  • K844368 — LINEAR LIFT DEVICE (February 19, 1985)
  • K843739 — CYBEX TORSO TESTING & REHABILITATION (November 29, 1984)

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