Company ยท US
Breg, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2019. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
13recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 1, 2019 | K183702 | Polar Care Wave Breg, Inc. | IRP |
| Mar 29, 2007 | K070402 | MODIFICATION TO POLAR CARE 500 Breg, Inc. | ILO |
| Oct 1, 2004 | K041714 | E-PAIN CARE Breg, Inc. | FRN |
| Apr 4, 2002 | K020988 | PAIN CARE 4200 Breg, Inc. | MEB |
| Dec 3, 2001 | K013928 | PAIN CARE 3200 Breg, Inc. | MEB |
| Dec 13, 2000 | K003611 | PAIN CARE MULTI-PORT CATHETER, MODEL 2000L Breg, Inc. | FRN |
| Sep 19, 2000 | K002073 | PAIN CARE 3000 Breg, Inc. | MEB |
| Aug 14, 2000 | K002321 | PAIN CARE 2000L Breg, Inc. | MEB |
| Dec 16, 1998 | K983454 | PAIN CARE 2000 Breg, Inc. | MEB |
| Dec 4, 1996 | K963596 | POLAR CARE 300 Breg, Inc. | ILO |
| Aug 9, 1996 | K961855 | POLAR CARE (MODEL 500/50000) Breg, Inc. | ILO |
| Oct 5, 1995 | K950755 | FLEXMATE K500 Breg, Inc. | BXB |
| Mar 20, 1992 | K920581 | POLAR PAD (STERILE) Breg, Inc. | ILO |
| Nov 19, 1991 | K911795 | KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000) Breg, Inc. | LXV |
| Oct 24, 1991 | K914434 | POLAR PADS Breg, Inc. | ILO |
| Oct 18, 1991 | K913729 | POLAR PUMP, MODEL 500 Breg, Inc. | ILO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2023 | Breg Inc BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS
Utilized as a walking aid. Open, Classified |
ITJ | None listed |
| May 2, 2017 | Breg Inc If Hip, Sterile Polar Dressing P/N 10680
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 Terminated |
KGX | None listed |
| May 2, 2017 | Breg Inc Dressing Back, P/N 09810
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 applie Terminated |
KGX | None listed |
| May 2, 2017 | Breg Inc Dressing Shldr XL, P/N 04918
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 ap Terminated |
KGX | None listed |
| May 2, 2017 | Breg Inc Dressing Shldr, P/N 04908
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 appli Terminated |
KGX | None listed |
| May 2, 2017 | Breg Inc Dressing, Knee L/XL, P/N 04708
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 Terminated |
KGX | None listed |
| May 2, 2017 | Breg Inc Dressing Rect L, P/N 02428
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 appl Terminated |
KGX | None listed |
| May 2, 2017 | Breg Inc Dressing M/U XL, P/N 02344
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 appl Terminated |
KGX | None listed |
| May 2, 2017 | Breg Inc 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 Terminated |
KGX | None listed |
| Apr 10, 2014 | Breg Inc K-Lite Knee 2 Stays with Visco, Model No. 122015.
Product Usage:
The product is intended to provide flexible knee support. Terminated |
IQI | None listed |
| Apr 10, 2014 | Breg Inc Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415.
Product Usage: The product is intended to provide flexible knee support. Terminated |
IQI | None listed |
| Feb 12, 2013 | Breg Inc BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect. Terminated |
ILO | K920581 |
| Feb 12, 2013 | Breg Inc 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 a Terminated |
ILO | None listed |