BREG, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3010694026	3010694026	BREG, INC.	1	N	2026-01-01	2835 Fortune Cir W Indianapolis IN US 46241
1640542	1640542	BREG, INC.	1	Y	2020-04-25	2601 Pinewood Dr GRAND PRAIRIE TX US 75051

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00672736022283	BREG - 1 Ice Water Container, 1 6 VDC output and 120 VAC 60 Hz input transformer	8003210607	xx@xx.xx

xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
165611	1745531915	K914434	POLAR PADS	ILO	1991-10-24
165611	1218647730	K202839	Overlapped Compression Therapy	JOW	2021-01-21
165611	1061765078	K183702	Polar Care Wave	IRP	2019-03-01
165611	1394462569	K122640	VPULSE	JOW	2013-02-22
165611	1016623881
165611	1030317189
165611	1048061221
165611	1057703401
165611	1067057488
165611	1083941247
165611	1102412823
165611	1127304553
165611	1207396988
165611	1369673492
165611	1379087333
165611	1428735278
165611	1465081596
165611	1476036126
165611	1503823017
165611	1566335700
165611	1657133116
165611	1713865551
165611	1717113638
165611	1718163176
165611	1744807198
165611	1750783527
165611	1785127776
165611	1799816946
165611	1822897266
165611	1840340271
165611	1849380705
165611	1860457461
165611	1916888317
165611	1955037612
165611	2016820494

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
JOW	2	2021-01-21
IRP	1	2019-03-01
ILO	1	1991-10-24

PMN#

MODIFICATION TO POLAR CARE 500
2007-03-29
BREG, INC.
E-PAIN CARE
2004-10-01
BREG, INC.
PAIN CARE 3200
2001-12-03
BREG, INC.
PAIN CARE MULTI-PORT CATHETER, MODEL 2000L
2000-12-13
BREG, INC.
PAIN CARE 3000
2000-09-19
BREG, INC.
PAIN CARE 2000L
2000-08-14
BREG, INC.
PAIN CARE 2000
1998-12-16
BREG, INC.
POLAR CARE 300
1996-12-04
BREG, INC.
POLAR CARE (MODEL 500/50000)
1996-08-09
BREG, INC.
FLEXMATE K500
1995-10-05
BREG, INC.
POLAR PAD (STERILE)
1992-03-20
BREG, INC.
KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)
1991-11-19
BREG, INC.
POLAR PADS
1991-10-24
BREG, INC.
POLAR PUMP, MODEL 500
1991-10-18
BREG, INC.

GUDID#

BREG - DVT GUARDIAN
BREG, INC.
2026-06-25
BREG - WRAPON PAD, HIP, WITH 29 IN STRAPS
BREG, INC.
2025-07-01
BREG - 1 Ice Water Container, 1 6 VDC output and 120 VAC 60 Hz input transformer
BREG, INC.
2016-08-15
BREG - 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10240 I-Flo MU Pad
BREG, INC.
2016-08-15
BREG - 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10220 I-Flo Shoulder Pad
BREG, INC.
2016-08-15
BREG - POLAR CARE WAVE INTL
BREG, INC.
2024-11-19
BREG - 1 Ice Water Container, 1 12 VDC, 24W output 100-240V 50/60 Hz input transformer
BREG, INC.
2016-08-15
BREG - 1 Ice Water Container, 1 12 VDC, 24W output 100-240V 50/60 Hz input transformer and 2 Sequential Calf Pads
BREG, INC.
2016-08-15
BREG - PAD INTELLI FLO 3X5
BREG, INC.
2016-08-15
BREG - 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10240 I-Flo MU Pad
BREG, INC.
2016-08-15
BREG - 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10230 I-Flo Knee Pad
BREG, INC.
2016-08-15
BREG - 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10225 I-Flo Shoulder XL Pad
BREG, INC.
2016-08-15
BREG - 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10245 I-Flo MU Long-Stem Pad
BREG, INC.
2016-08-15
BREG - 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10220 I-Flo Shoulder Pad
BREG, INC.
2016-08-15
BREG - 1 Ice Water Container, 1 6 VDC output and 120 VAC 60 Hz input transformer
BREG, INC.
2016-08-15
BREG - 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10210 I-Flo Ankle Pad
BREG, INC.
2016-08-15
BREG - 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10235 I-Flo Knee Comp Pad
BREG, INC.
2016-08-15
BREG - 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10250 I-Flo Back Pad
BREG, INC.
2016-08-15
BREG - 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10215 I-Flo Ankle Comp Pad
BREG, INC.
2016-08-15
BREG - STRAP IF PAD COMPRESSION
BREG, INC.
2016-08-15
BREG - IF KODIAK -Y- ADAPTER
BREG, INC.
2016-08-15
BREG - POLAR CARE Y IN ADAPTOR
BREG, INC.
2016-08-15
BREG - PAD M/U XL
BREG, INC.
2016-08-15
BREG - PAD KNEE/SHLDR
BREG, INC.
2016-08-15
BREG - PAD M/U
BREG, INC.
2016-08-15
BREG - PAD RECT S
BREG, INC.
2016-08-15
BREG - PAD M/U XL LS
BREG, INC.
2016-08-15
BREG - PAD ANKLE
BREG, INC.
2016-08-15
BREG - PAD M/U LS
BREG, INC.
2016-08-15
BREG - PAD SHLDR WO
BREG, INC.
2016-08-15
BREG - PAD SHLDR XL WO
BREG, INC.
2016-08-15
BREG - PAD SHLDR W/LONG STRAPS WO
BREG, INC.
2016-08-15
BREG - PAD KNEE XL WO
BREG, INC.
2016-08-15
BREG - PAD RECT L
BREG, INC.
2016-08-15
BREG - PAD RECT LG LS
BREG, INC.
2016-08-15
BREG - PAD KNEE WO
BREG, INC.
2016-08-15
BREG - PAD M/U XL WO
BREG, INC.
2016-08-15
BREG - PAD KNEE L WO
BREG, INC.
2016-08-15
BREG - PAD BACK W/LONG STRPS WO
BREG, INC.
2016-08-15
BREG - PAD M/U XL LS WO
BREG, INC.
2016-08-15

200 records. Showing 1-40. Next