Medical Device Manufacturer · US , Vernon Hills , IL

Omron Healthcare, Inc. - FDA 510(k) Cleared Devices

68 submissions · 67 cleared · Since 1991

68

Total

67

Cleared

1

Denied

FDA 510(k) cleared devices by Omron Healthcare, Inc. Neurology ✕

8 devices

1-8 of 8

Cleared Sep 07, 2019

Focus TENS Therapy, Model PM710-M/-L

Neurology · 292d

Cleared Jan 10, 2019

Maxpower Relief

Neurology · 157d

Cleared Nov 09, 2018

Neurology · 106d

Cleared Oct 19, 2017

Neurology · 101d

Cleared Jun 03, 2016

Neurology · 136d

Cleared Dec 03, 2014

MAXPOWER RELIEF

Neurology · 135d

Cleared May 17, 2012

LONG LIFE PADTM

Neurology · 86d

Cleared Dec 08, 2011

Neurology · 332d