Medical Device Manufacturer · US , Costa Mesa , CA

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

16 submissions · 16 cleared · Since 1991

Total

Cleared

Denied

Breg, Inc. has 16 FDA 510(k) cleared medical devices. Based in Costa Mesa, US.

Historical record: 16 cleared submissions from 1991 to 2019. Primary specialty: Physical Medicine.

Browse the FDA 510(k) cleared devices submitted by Breg, Inc. Filter by specialty or product code using the sidebar.

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

16 devices

1-16 of 16

Cleared Mar 01, 2019

Polar Care Wave

K183702 · IRP

Physical Medicine · 60d

Cleared Mar 29, 2007

MODIFICATION TO POLAR CARE 500

K070402 · ILO

Physical Medicine · 45d

Cleared Oct 01, 2004

E-PAIN CARE

K041714 · FRN

General Hospital · 100d

Cleared Apr 04, 2002

PAIN CARE 4200

K020988 · MEB

General Hospital · 8d

Cleared Dec 03, 2001

PAIN CARE 3200

K013928 · MEB

General Hospital · 5d

Cleared Dec 13, 2000

PAIN CARE MULTI-PORT CATHETER, MODEL 2000L

K003611 · FRN

General Hospital · 21d

Cleared Sep 19, 2000

PAIN CARE 3000

K002073 · MEB

General Hospital · 71d

Cleared Aug 14, 2000

PAIN CARE 2000L

K002321 · MEB

General Hospital · 14d

Cleared Dec 16, 1998

PAIN CARE 2000

K983454 · MEB

General Hospital · 77d

Cleared Dec 04, 1996

POLAR CARE 300

K963596 · ILO

Physical Medicine · 86d

Cleared Aug 09, 1996

POLAR CARE (MODEL 500/50000)

K961855 · ILO

Physical Medicine · 87d

Cleared Oct 05, 1995

FLEXMATE K500

K950755 · BXB

Physical Medicine · 230d

Cleared Mar 20, 1992

POLAR PAD (STERILE)

K920581 · ILO

Physical Medicine · 39d

Cleared Nov 19, 1991

KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)

K911795 · LXV

Ear, Nose, Throat · 211d

Cleared Oct 24, 1991

POLAR PADS

K914434 · ILO

Physical Medicine · 20d

Cleared Oct 18, 1991

POLAR PUMP, MODEL 500

K913729 · ILO

Physical Medicine · 59d

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

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

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