Breg Inc

FDA Regulatory Profile

Summary

Total Recalls
13
510(k) Clearances
16
Inspections
3
Compliance Actions
0

Known Names

breg, breg, inc

Recent Recalls

NumberClassProductDate
Z-0231-2024Class IIBREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.September 13, 2023
Z-1905-2017Class IIDressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulatMarch 30, 2017
Z-1901-2017Class IIDressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an inMarch 30, 2017
Z-1906-2017Class IIDressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insuMarch 30, 2017
Z-1903-2017Class IIDressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insulaMarch 30, 2017
Z-1907-2017Class IIDressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an insulatiMarch 30, 2017
Z-1908-2017Class IIIf Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile dressings useMarch 30, 2017
Z-1904-2017Class IIDressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an inMarch 30, 2017
Z-1902-2017Class IIDressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulaMarch 30, 2017
Z-1447-2014Class IIK-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provMarch 14, 2014
Z-1446-2014Class IIEconomy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is inteMarch 14, 2014
Z-0803-2013Class IIBREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, MfJanuary 14, 2013
Z-0804-2013Class IIBREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 023January 14, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K183702Polar Care WaveMarch 1, 2019
K070402MODIFICATION TO POLAR CARE 500March 29, 2007
K041714E-PAIN CAREOctober 1, 2004
K020988PAIN CARE 4200April 4, 2002
K013928PAIN CARE 3200December 3, 2001
K003611PAIN CARE MULTI-PORT CATHETER, MODEL 2000LDecember 13, 2000
K002073PAIN CARE 3000September 19, 2000
K002321PAIN CARE 2000LAugust 14, 2000
K983454PAIN CARE 2000December 16, 1998
K963596POLAR CARE 300December 4, 1996
K961855POLAR CARE (MODEL 500/50000)August 9, 1996
K950755FLEXMATE K500October 5, 1995
K920581POLAR PAD (STERILE)March 20, 1992
K911795KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)November 19, 1991
K914434POLAR PADSOctober 24, 1991
K913729POLAR PUMP, MODEL 500October 18, 1991