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510(k) K904823

FLEXERCYCLE by Medmetric Corp. — Product Code ISD

K904823 is an FDA 510(k) premarket notification submitted by Medmetric Corp. for the device "FLEXERCYCLE". The FDA issued a decision of Substantially Equivalent on January 30, 1991. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360. Medmetric Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1991
Date Received
October 25, 1990
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 Medmetric Corp.

  • K943197 — KT1000/S KNEE LIGAMENT ARTHROMETER (March 2, 1995)
  • K942059 — KT2000 KNEE LIGAMENT ARTHROMETER (September 20, 1994)
  • K904898 — TORQUE FRAME QTF1000 (November 28, 1990)
  • K854254 — TENSION-ISOMETER (November 15, 1985)
  • K812806 — KT-1000 DEVICE (November 10, 1981)
  • K812713 — DRAWER TEST (November 5, 1981)
  • K801572 — SURG-ASSIST (August 4, 1980)

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