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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