ISD · Class II · 21 CFR 890.5360

FDA Product Code ISD: Exerciser, Measuring

Leading manufacturers include Quinton, Inc., Penumbra, Inc. and Lode B.V..

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 Apr 29, 1999
QUINTON MEDTRACK CR PLUS TREADMILL
K990866
Quinton, Inc.
Physical Medicine · 44d
Cleared Aug 07, 1991
MONARK ERGOMETERS
K912227
Quinton, Inc.
Physical Medicine · 83d
Cleared Feb 03, 1988
RESUBMITTED EXCALIBUR
K880271
Quinton, Inc.
Physical Medicine · 13d
Cleared Feb 14, 1977
MODEL 880 REHABILITATION TRAINER
K770234
Quinton, Inc.
Physical Medicine · 7d

About Product Code ISD - Regulatory Context