Medical Device Manufacturer · US , Costa Mesa , CA

Breg, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1991

16

Total

16

Cleared

0

Denied

FDA 510(k) cleared devices by Breg, Inc. Physical Medicine ✕

8 devices

1-8 of 8

Cleared Mar 01, 2019

Polar Care Wave

Physical Medicine · 60d

Cleared Mar 29, 2007

MODIFICATION TO POLAR CARE 500

Physical Medicine · 45d

Cleared Dec 04, 1996

Physical Medicine · 86d

Cleared Aug 09, 1996

POLAR CARE (MODEL 500/50000)

Physical Medicine · 87d

Cleared Oct 05, 1995

Physical Medicine · 230d

Cleared Mar 20, 1992

POLAR PAD (STERILE)

Physical Medicine · 39d

Cleared Oct 24, 1991

Physical Medicine · 20d

Cleared Oct 18, 1991

POLAR PUMP, MODEL 500

Physical Medicine · 59d