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510(k) K080545

ACTITRAINER by Actigraph, LLC — Product Code ISD

K080545 is an FDA 510(k) premarket notification submitted by Actigraph, LLC for the device "ACTITRAINER". The FDA issued a decision of Substantially Equivalent on July 24, 2008. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360. Actigraph, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2008
Date Received
February 27, 2008
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 Actigraph, LLC

  • K231532 — ActiGraph LEAP activity monitor (ActiGraph LEAP) (June 23, 2023)
  • K181077 — ActiGraph CentrePoint Insight Watch (May 24, 2018)

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)
  • 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