ISD · Class II · 21 CFR 890.5360

FDA Product Code ISD: Exerciser, Measuring

Leading manufacturers include Henley Intl., Quinton, Inc. and Biodan Medical Systems, Ltd..

61
Total
61
Cleared
139d
Avg days
1977
Since

FDA 510(k) Cleared Exerciser, Measuring Devices (Product Code ISD)

61 devices
1–24 of 61
Cleared Dec 21, 2020
MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
K202979
Lode B.V.
Physical Medicine · 82d
Cleared Mar 18, 2019
REAL Immersive System
K183296
Penumbra, Inc.
Physical Medicine · 111d
Cleared Aug 26, 2015
ActiSpec Activity Monitor
K143512
Sleep Modus, Inc.
Physical Medicine · 258d
Cleared Oct 31, 2012
ERGOSELECT/GE
K112121
Ergoline GmbH
Physical Medicine · 464d
Cleared Jul 24, 2008
ACTITRAINER
K080545
Actigraph, LLC
Physical Medicine · 148d
Cleared Apr 27, 2006
ERGOSELECT 100 K/P, ERGOSELECT 200 K/P
K053078
Ergoline GmbH
Physical Medicine · 176d
Cleared Apr 29, 1999
QUINTON MEDTRACK CR PLUS TREADMILL
K990866
Quinton, Inc.
Physical Medicine · 44d
Cleared Apr 12, 1999
REHCOR
K990813
Electromed Corp.
Physical Medicine · 32d
Cleared Dec 11, 1996
ULE-2, MULE-2, HAND ACCESSORY KIT
K962855
Penny and Giles Biometrics , Ltd.
Physical Medicine · 142d
Cleared Aug 12, 1996
DAVID BACK CLINIC SYSTEM
K952163
Kinetic Resources, Inc.
Physical Medicine · 462d
Cleared May 05, 1994
STAIR CLIMBER
K926278
Henley Intl.
Physical Medicine · 507d
Cleared May 05, 1994
UPPER BODY EXERCISER
K926279
Henley Intl.
Physical Medicine · 507d
Cleared Mar 22, 1994
EXERCISE BICYCLE
K926287
Henley Intl.
Physical Medicine · 463d
Cleared Mar 18, 1994
HYDRA FITNESS MODEL 311 TOTAL POWER
K926314
Henley Intl.
Physical Medicine · 458d
Cleared Jun 19, 1992
CABLE COLUMN WEIGHT SYSTEM MODEL #940-200
K922602
Biodan Medical Systems, Ltd.
Physical Medicine · 17d
Cleared Jun 19, 1992
TOTAL WORK INTEGRATOR, MODEL #940-110
K922603
Biodan Medical Systems, Ltd.
Physical Medicine · 17d
Cleared Jun 19, 1992
MULTI JOINT WEIGHT SYSTEM MODEL #940-100
K922606
Biodan Medical Systems, Ltd.
Physical Medicine · 17d
Cleared Aug 07, 1991
MONARK ERGOMETERS
K912227
Quinton, Inc.
Physical Medicine · 83d
Cleared Feb 11, 1988
MEDEX MACHINE
K880032
Medex, Inc.
Physical Medicine · 37d
Cleared Feb 03, 1988
RESUBMITTED EXCALIBUR
K880271
Quinton, Inc.
Physical Medicine · 13d
Cleared May 02, 1986
R1361 & R1372 MEASURED EXERCISE EQUIPMENT
K861348
Tri W-G, Inc.
Physical Medicine · 25d
Cleared Nov 27, 1984
UNIVERSAL-ERGOTEST
K843850
Erich Jaeger, Inc.
Physical Medicine · 57d
Cleared May 14, 1980
NUCLEAR STRESS TABLE (NST-1)
K800892
Technicare Corp.
Physical Medicine · 26d
Cleared Jan 04, 1980
STRESS TABLE/ERGOMETER SYSTEM
K792591
Victoreen, Inc.
Radiology · 18d

About Product Code ISD - Regulatory Context