# Breg, Inc.

- Location (FDA's records): Vista, CA
- FDA decisions: 16 (1991–2019): 16 510(k) clearances
- Product codes: ILO (6), MEB (5), FRN (2), BXB (1), LXV (1), IRP (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 10 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Coolsystems, Inc.: 1 (https://510kreport.com/company/coolsystems)
- Cool Systems, Inc. (Dba Game Ready): 1 (https://510kreport.com/company/cool-systems-dba-game-ready)

## Firms that cite its devices most
- Mark H. Friedman: 2 (https://510kreport.com/company/mark-h-friedman)
- Sportkat, LLC: 1 (https://510kreport.com/company/sportkat)
- Advanced Infusion, Inc.: 1 (https://510kreport.com/company/advanced-infusion)
- Jkh Health Co., Ltd.: 1 (https://510kreport.com/company/jkh-health)
- Coolsystems, Inc.: 1 (https://510kreport.com/company/coolsystems)
- Mckinley Infuser: 1 (https://510kreport.com/company/mckinley-infuser)
- Shenzhen Xinrun Electric Appliances Co, Ltd.: 1 (https://510kreport.com/company/shenzhen-xinrun-electric-appliances)
- Pain Management Technologies: 1 (https://510kreport.com/company/pain-management-technologies)

## Its most-cited devices
- K183702: Polar Care Wave (2019), cited by 3
- K914434: Polar Pads (1991), cited by 1
- K013928: Pain Care 3200 (2001), cited by 1
- K911795: Kinesthetic Ability Trainer (K.a.T., Model 1000) (1991), cited by 1
- K961855: Polar Care (Model 500/50000) (1996), cited by 1
- K983454: Pain Care 2000 (1998), cited by 1

## Recent decisions
- K183702: Polar Care Wave (Mar 1, 2019)
- K070402: Modification to Polar Care 500 (Mar 29, 2007)
- K041714: E-Pain Care (Oct 1, 2004)
- K020988: Pain Care 4200 (Apr 4, 2002)
- K013928: Pain Care 3200 (Dec 3, 2001)
- K003611: Pain Care Multi-Port Catheter, Model 2000L (Dec 13, 2000)
- K002073: Pain Care 3000 (Sep 19, 2000)
- K002321: Pain Care 2000L (Aug 14, 2000)

Source page: https://510kreport.com/company/breg