FDA 510(k) Applications for Medical Device Product Code "ISD"
(Exerciser, Measuring)

FDA 510(k) Number Applicant Device Name Decision Date
K080545 ACTIGRAPH, LLC ACTITRAINER 07/24/2008
K990813 ELECTROMED CORP. REHCOR 04/12/1999
K053078 ERGOLINE GMBH ERGOSELECT 100 K/P, ERGOSELECT 200 K/P 04/27/2006
K112121 ERGOLINE GMBH ERGOSELECT/GE 10/31/2012
K952163 KINETIC RESOURCES, INC. DAVID BACK CLINIC SYSTEM 08/12/1996
K202979 Lode B.V. MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra 12/21/2020
K962855 PENNY AND GILES BIOMETRICS LTD. ULE-2, MULE-2, HAND ACCESSORY KIT 12/11/1996
K183296 Penumbra, Inc. REAL Immersive System 03/18/2019
K990866 QUINTON, INC. QUINTON MEDTRACK CR PLUS TREADMILL 04/29/1999
K143512 SLEEP MODUS, INC. ActiSpec Activity Monitor 08/26/2015


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