Data / Medical devices / United States / Breg, Inc.
Breg, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 4 510(k) clearances
Breg, Inc. is registered with the FDA (registration 2028253) in Carlsbad, CA, United States. It lists 30 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 21, 2021. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2028253
- FEI number
- 1000125378
- Address
- 2382 Faraday Avenue Suite 300, Carlsbad, CA, United States, 92008
- Owner or operator
- Breg Inc (10041297)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- July 10, 2012
- Registered through
- 2026
- Brand names listed
- 20.50 Patellofemoral, ABDUCTION PILLOW CONTOURED, ADJ DONUT, ADJ NIGHT SPLINT, ALIGNER PHX, ARC DYNAMIC, Abdominal Binder, Accessories - Back Panel, Front Panel, Pad Kit, Upgrade Kit, Conversion Kit, Pads and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 21, 2021 | K202839 | Overlapped Compression Therapy | JOW | Substantially Equivalent | Jkh Health Co., Ltd. | accessdata.fda.gov |
| March 1, 2019 | K183702 | Polar Care Wave | IRP | Substantially Equivalent | Breg, Inc. | accessdata.fda.gov |
| February 22, 2013 | K122640 | VPULSE | JOW | Substantially Equivalent | Cothera, LLC | accessdata.fda.gov |
| October 24, 1991 | K914434 | POLAR PADS | ILO | Substantially Equivalent | Breg, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 13, 2023 | 93114 | Class II | Ongoing | BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid. | Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels. | accessdata.fda.gov |
| March 30, 2017 | 76994 | Class II | Terminated | Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-ster | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. | accessdata.fda.gov |
| March 14, 2014 | 67821 | Class II | Terminated | Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support. | 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. | accessdata.fda.gov |
| January 14, 2013 | 64177 | Class II | Terminated | BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect. | 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. | accessdata.fda.gov |
| August 11, 2010 | 58247 | Class II | Terminated | Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin. | This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. The dressing in the sterile pouch measures a thickness of 0.010" instead of 0.020". This change in thickness makes the dressing thinner, less durable and subject to tearing. The product is mislabeled. | accessdata.fda.gov |
| June 18, 2009 | 52775 | Not yet classified | Terminated | Power Supply Accessory (model AD-0660G) Power supply accessory is used with the Polar Care Kodiak unit, a motorized cold-therapy device. The Power Supply is plugged into a standard electrical wall socket and provides low | Power supplies short-circuited at the electrical outlet upon initial use of the power supply, causing the circuit breaker for the electrical outlet to trip. | accessdata.fda.gov |
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Updated November 3, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.