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Breg, Inc.

United States·US-MF-000018362

Last updated September 17, 2026

Information

Country: United States
Address: 2382, Faraday Avenue, Suite 300, Carlsbad, United States
Website: breg.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 8003210607
PRRC Contact: Monique Zamora
EUDAMED SRN: US-MF-000018362
FDA FEI Number: 3010694026
DUNS Number: 604483321

Catalogue (251)

Page 5 of 6

Device	Model / Reference	Registries	Class	Status
Breg	DRESSING IF STER KNEE MU SHLDR	FDA UDI	Class I	Active
Breg	PC KODIAK COMBO IFP KNEE	FDA UDI	Class II	Active
Breg	VPULSE THRM CMP PAD KNEE L NO LNR	FDA UDI	Class II	Unknown
Breg	NOVAPLUS PC KODIAK W/ IF MU	FDA UDI	Class II	Active
Breg	DRESSING SHLDR	FDA UDI	Class I	Active
Breg	PAD TMJ	FDA UDI	Class II	Active
Breg	NOVAPLUS WO PAD M/U LS XL	FDA UDI	Class II	Active
If Pad Knee Intl	100294-000	EUDAMEDFDA UDI	Class I	Active
If Pad Mu Ls Intl	100297-000	EUDAMEDFDA UDI	Class I	Active
If Pad Knee Comp Intl	100295-000	EUDAMEDFDA UDI	Class I	Active
Breg Ice Bags	100582-000	EUDAMED	Class I	Active
Kinesthetic Ability Trainer (k.a.t., Model 1000)	K911795	FDA 510(k)	U	Active
Polar Care (model 500/50000)	K961855	FDA 510(k)	Class II	Active
Flexmate K500	K950755	FDA 510(k)	Class I	Active
E-Pain Care	K041714	FDA 510(k)	Class II	Active
Pain Care 4200	K020988	FDA 510(k)	Class II	Active
Pain Care 2000l	K002321	FDA 510(k)	Class II	Active
Pain Care Multi-Port Catheter, Model 2000l	K003611	FDA 510(k)	Class II	Active
Polar Pump, Model 500	K913729	FDA 510(k)	Class II	Active
Polar Pads	K914434	FDA 510(k)	Class II	Active
Modification To Polar Care 500	K070402	FDA 510(k)	Class II	Active
Polar Pad (sterile)	K920581	FDA 510(k)	Class II	Active
Polar Care 300	K963596	FDA 510(k)	Class II	Active
Pain Care 3000	K002073	FDA 510(k)	Class II	Active
Pain Care 2000	K983454	FDA 510(k)	Class II	Active
Pain Care 3200	K013928	FDA 510(k)	Class II	Active
If Pad Shoulder Xl Intl	100293-000	EUDAMEDFDA UDI	Class I	Active
Post Op Tscope Premier	08814	EUDAMED	Class I	Active
Breg Cold Compression Pad, Foot/Ankle	C00005	EUDAMEDFDA UDI	Class I	Active
Strap If Pad Compression	10670	EUDAMEDFDA UDI	Class I	Active
If Pad Back Intl	100300-000	EUDAMEDFDA UDI	Class I	Active
Breg Cold Compression Pad, Hip	C00013	EUDAMEDFDA UDI	Class I	Active
Undersleeve, Cotton, Xs	09851	EUDAMED	Class I	Active
Pc Wave Knee Y Adapter	100576-000	EUDAMEDFDA UDI	Class I	Active
Pc Kodiak Intl	100291-000	EUDAMEDFDA UDI	Class IIa	Active
Breg Cold Compression Pad, Shoulder	C00004	EUDAMEDFDA UDI	Class I	Active
Breg Cold Compression Pad, Knee L	C00003	EUDAMEDFDA UDI	Class I	Active
Breg Cold Compression Pad, Universal	C00016	EUDAMEDFDA UDI	Class I	Active
Polar Care Wave Intl	100716-000	EUDAMEDFDA UDI	Class IIa	Active
If Pad Ankle Intl	100298-000	EUDAMEDFDA UDI	Class I	Active
If Pad Shoulder Intl	100292-000	EUDAMEDFDA UDI	Class I	Active
If Pad Mu Intl	100296-000	EUDAMEDFDA UDI	Class I	Active
If Pad 3x5 Intl	100301-000	EUDAMEDFDA UDI	Class I	Active
If Pad Ankle Comp Intl	100392-000	EUDAMEDFDA UDI	Class I	Active
If Kodiak -y- Adapter	10699	EUDAMEDFDA UDI	Class I	Active
Breg Cold Compression Pad, Back	C00020	EUDAMEDFDA UDI	Class I	Active
If Pad Hip Intl	100302-000	EUDAMEDFDA UDI	Class I	Active
Breg Cold Compression Pad, Knee	C00017	EUDAMEDFDA UDI	Class I	Active
If Pad Hand/Wrist Intl	100303-000	EUDAMEDFDA UDI	Class I	Active
Battery Pack, 4aa, Pc Kodiak	97050	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (13)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 13, 2023	Z-0231-2024	—	open, classified	Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.
Mar 30, 2017	Z-1902-2017	—	terminated	They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Mar 30, 2017	Z-1906-2017	—	terminated	They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Mar 30, 2017	Z-1904-2017	—	terminated	They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Mar 30, 2017	Z-1905-2017	—	terminated	They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Mar 30, 2017	Z-1903-2017	—	terminated	They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Mar 30, 2017	Z-1908-2017	—	terminated	They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Mar 30, 2017	Z-1907-2017	—	terminated	They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Mar 30, 2017	Z-1901-2017	—	terminated	They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Mar 14, 2014	Z-1447-2014	—	terminated	Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.
Mar 14, 2014	Z-1446-2014	—	terminated	Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.
Jan 14, 2013	Z-0804-2013	—	terminated	The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.
Jan 14, 2013	Z-0803-2013	—	terminated	The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.