Data / Medical devices / Mexico / Breg Mexico, S. De R.L. De C.V. (3)
Breg Mexico, S. De R.L. De C.V. (3): FDA-registered device maker in Mexicali Baja California, Mexico, 1 510(k) clearance
Breg Mexico, S. De R.L. De C.V. (3) is registered with the FDA (registration 3015960622) in Mexicali Baja California, Mexico. It lists 17 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 1, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015960622
- Address
- Avenida Circulo De La Amistad #2701 Parque Industrial Pimsa Iv, Mexicali Baja California, Mexico, 21229
- Owner or operator
- Breg Inc (10041297)
- Roles
- Manufacturer
- First device listed
- July 10, 2012
- Registered through
- 2026
- Brand names listed
- 20.50 Patellofemoral, ADJ DONUT, ADJ NIGHT SPLINT, ALIGNER PHX, ARC DYNAMIC, Abdominal Binder, Accessories - Back Panel, Front Panel, Pad Kit, Upgrade Kit, Conversion Kit, Pads, Accessories - Condyle and Hook, Patella Buttress, Strap set, Strap Tab, Strap Pad, Calf Strap, Condyle, Hex Key and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Components, Exercise | IOD | 1 | Manufacturer | accessdata.fda.gov |
| Cover, Limb | IPM | 1 | Manufacturer | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Manufacturer | accessdata.fda.gov |
| Joint, Hip, External Brace | ITS | 1 | Manufacturer | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Abdominal | KTD | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Rib Fracture, Soft | IPX | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Thoracic | IPT | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Truncal/Orthosis, Limb | MRI | 1 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Manufacturer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Manufacturer | accessdata.fda.gov |
| Splint, Clavicle | IQJ | 1 | Manufacturer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| March 1, 2019 | K183702 | Polar Care Wave | IRP | Substantially Equivalent | Breg, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Components, Exercise
- All makers of Joint, Ankle, External Brace
- All makers of Orthosis, Limb Brace
- All makers of Pack, Hot Or Cold, Water Circulating
- All makers of Massager, Powered Inflatable Tube
- All makers of Orthosis, Thoracic
Updated March 1, 2019. 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.