Breg Inc
Breg Inc appears in FDA public data with 13 recalls, 16 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0231-2024, Class II) was initiated on September 13, 2023. Its most recent 510(k) clearance was granted on March 1, 2019.
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 16
- Inspections
- 3
- Compliance Actions
- 0
Known Names
breg, breg, inc
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0231-2024 | Class II | BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid. | September 13, 2023 |
| Z-1905-2017 | Class II | Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulat | March 30, 2017 |
| Z-1901-2017 | Class II | Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an in | March 30, 2017 |
| Z-1903-2017 | Class II | Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insula | March 30, 2017 |
| Z-1906-2017 | Class II | Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insu | March 30, 2017 |
| Z-1902-2017 | Class II | Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insula | March 30, 2017 |
| Z-1907-2017 | Class II | Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an insulati | March 30, 2017 |
| Z-1904-2017 | Class II | Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an in | March 30, 2017 |
| Z-1908-2017 | Class II | If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile dressings use | March 30, 2017 |
| Z-1447-2014 | Class II | K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to prov | March 14, 2014 |
| Z-1446-2014 | Class II | Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is inte | March 14, 2014 |
| Z-0803-2013 | Class II | BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mf | January 14, 2013 |
| Z-0804-2013 | Class II | BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 023 | January 14, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K183702 | Polar Care Wave | March 1, 2019 |
| K070402 | MODIFICATION TO POLAR CARE 500 | March 29, 2007 |
| K041714 | E-PAIN CARE | October 1, 2004 |
| K020988 | PAIN CARE 4200 | April 4, 2002 |
| K013928 | PAIN CARE 3200 | December 3, 2001 |
| K003611 | PAIN CARE MULTI-PORT CATHETER, MODEL 2000L | December 13, 2000 |
| K002073 | PAIN CARE 3000 | September 19, 2000 |
| K002321 | PAIN CARE 2000L | August 14, 2000 |
| K983454 | PAIN CARE 2000 | December 16, 1998 |
| K963596 | POLAR CARE 300 | December 4, 1996 |
| K961855 | POLAR CARE (MODEL 500/50000) | August 9, 1996 |
| K950755 | FLEXMATE K500 | October 5, 1995 |
| K920581 | POLAR PAD (STERILE) | March 20, 1992 |
| K911795 | KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000) | November 19, 1991 |
| K914434 | POLAR PADS | October 24, 1991 |
| K913729 | POLAR PUMP, MODEL 500 | October 18, 1991 |