Breg
1 Ice Water Container, 1 6 VDC output and 120 VAC 60 Hz input transformer and 1 04905 WO XL Shoulder Polar Pad
45manufacturers in China registered for this device type
135catalogue numbers in this listing
6510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (17), Zhejiang (6), Fujian (5). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo MPF Manufacturing Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Acot Plastics (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| Dongguan Kaiser Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| Wealthy Plastic & Electronic Products Company Limited | Huizhou | Guangdong | Contract manufacturer | 6 |
| Chengdu Cryo-Push Medical Technology Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 4 |
| Zhejiang E-Cozy Electronic Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Xiamen Ortocare Sports Health Co., Ltd. | Xiamen Free Trade Zone | Fujian | Contract manufacturer | 32 |
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang | Hebei | Manufacturer | 29 |
Showing 12 of 45. All 45 manufacturers in China registered for Pack, Hot Or Cold, Water Circulating
Record
| Listed by | Breg, Inc., United States |
|---|---|
| FDA product code | ILO |
| Device type | Pack, Hot Or Cold, Water Circulating |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5720 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-08-15 |
| Record revised | 2025-06-13 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment temperature -25 to 70 °C |
| Packaging | Bulk 4 pack of 4, bulk 6 pack of 6, bulk 20 pack of 20 |
| Distribution end date | 2025-04-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NOVAPLUS WO KNEE L | In distribution | |
| PC CUBE W/ HIP WO | In distribution | |
| PC GLACIER W/ KNEE WO | In distribution | |
| NOVAPLUS PC CUBE W/ MU XL | In distribution | |
| PC KODIAK COMBO IFP MU LS | In distribution | |
| PAD ANKLE | In distribution | |
| PC CUBE W/ SHLDR XL WO | In distribution | |
| STRAP IF PAD COMPRESSION | In distribution | |
| PAD INTELLI FLO KNEE | In distribution | |
| NOVAPLUS PAD INTELLI FLO SHOULDER | In distribution | |
| PC CUBE W/ KNEE WO | In distribution | |
| PC GLACIER W/ SHLDR XL WO | In distribution | |
| NOVAPLUS PC KODIAK W/ IF SHLDR | In distribution | |
| PC GLACIER W/ M/U XL WO | In distribution | |
| NOVAPLUS PC CUBE W/ WO SHLDR XL | In distribution | |
| WRAPON PAD, HIP | In distribution | |
| NOVAPLUS PC CUBE W/ KNEE PAD | In distribution | |
| PAD INTELLI FLO SHOULDER | In distribution | |
| NOVAPLUS WO PAD M/U XL | In distribution | |
| POLAR CARE CUBE | In distribution | |
| IF PAD HAND/WRIST INTL | In distribution | |
| PAD KNEE WO | In distribution | |
| IF PAD SHOULDER XL INTL | In distribution | |
| IF PAD 3X5 INTL | In distribution | |
| PAD BACK WO | In distribution | |
| PAD M/U | In distribution | |
| NOVAPLUS PAD INTELLI FLO MULTI USE | In distribution | |
| PC KODIAK COMBO IFP MU | In distribution | |
| NOVAPLUS PC CUBE | In distribution | |
| POLAR CARE KODIAK | In distribution | |
| PC CUBE W/ SHLDR WO | In distribution | |
| NOVAPLUS PC CUBE W/ WO KNEE XL | In distribution | |
| PC KODIAK COMBO IFP ANKL | In distribution | |
| PAD TMJ | In distribution | |
| PAD ANKLE WO | In distribution | |
| IF PAD BACK INTL | In distribution | |
| PC KODIAK COMBO IFP ANKL CMP | In distribution | |
| POLAR CARE Y IN ADAPTOR | In distribution | |
| PC GLACIER W/ SHLDR WO | In distribution | |
| NOVAPLUS WO PAD SHLDR XL | In distribution | |
| PC CUBE W/ ANKLE WO | In distribution | |
| PAD EYE MASK | In distribution | |
| NOVAPLUS WO PAD M/U LS XL | In distribution | |
| PAD INTELLI FLO SHOULDER XL | In distribution | |
| PAD SHLDR XL WO | In distribution | |
| IF PAD KNEE COMP INTL | In distribution | |
| PAD INTELLI-FLO HIP | In distribution | |
| PAD BACK | In distribution | |
| NOVAPLUS POLAR PAD KNEE/SHLDR | In distribution | |
| PC CUBE W/ KNEE L WO | In distribution | |
| PC KODIAK COMBO IFP SHLDR XL | In distribution | |
| PAD RECT L | In distribution | |
| PAD KNEE L WO | In distribution | |
| PAD RECT LG LS | In distribution | |
| POLAR CARE GLACIER | In distribution | |
| PAD BACK W/LONG STRPS WO | In distribution | |
| PC CUBE W/ M/U XL WO | In distribution | |
| PC CUBE W/ M/U XL | In distribution | |
| PAD INTELLI FLO ANKLE S | In distribution | |
| NOVAPLUS POLAR CARE KODIAK | In distribution | |
| IF PAD SHOULDER INTL | In distribution | |
| PAD SHLDR W/LONG STRAPS WO | In distribution | |
| PC KODIAK W/O TRANSFORMER | In distribution | |
| PC GLACIER W/ M/U XL LS WO | In distribution | |
| NOVAPLUS WO PAD SHLDR | In distribution | |
| PAD KNEE XL WO | In distribution | |
| PC KODIAK INTL | In distribution | |
| NOVAPLUS PC KODIAK W/ IF MU | In distribution | |
| PC GLACIER W/ KNEE/SHLDR | In distribution | |
| PC KODIAK COMBO IFP KNEE | In distribution | |
| PAD SHLDR LT XL WO | In distribution | |
| PAD INTELLI FLO ANKLE | In distribution | |
| PAD M/U XL LS WO | In distribution | |
| PAD M/U XL LS | In distribution | |
| POLAR CARE KODIAK COMBO INT-FLO HIP | In distribution | |
| NOVAPLUS PC KODIAK W/ IF KNEE | In distribution | |
| PC GLACIER W/ KNEE XL WO | In distribution | |
| BATTERY PACK, 4AA, PC KODIAK | In distribution | |
| PAD M/U LS | In distribution | |
| WRAPON PAD, HIP, WITH 29 IN STRAPS | In distribution | |
| IF PAD ANKLE INTL | In distribution | |
| PC KODIAK COMBO IFP BACK | In distribution | |
| NOVAPLUS WO PAD KNEE | In distribution | |
| NON-ELASTIC STRAP IF PAD, HIP | In distribution | |
| PAD M/U XL WO | In distribution | |
| PAD HND/WRST WO | In distribution | |
| NOVAPLUS PAD INTELLI FLO KNEE | In distribution | |
| PC GLACIER W/ KNEE L WO | In distribution | |
| PAD INTELLI FLO MULTI USE LONG STEM | In distribution | |
| NOVAPLUS PC KODIAK W/ IF SHLDR XL | In distribution | |
| PAD INTELLI FLO 3X5 | In distribution | |
| NOVAPLUS PC KODIAK W/ IF MU LS | In distribution | |
| PC CUBE W/ KNEE/SHLDR | In distribution | |
| IF PAD KNEE INTL | In distribution | |
| IF KODIAK -Y- ADAPTER | In distribution | |
| PAD KNEE/SHLDR | In distribution | |
| PAD INTELLI-FLO BACK | In distribution | |
| NOVAPLUS WO PAD KNEE XL | In distribution | |
| PAD SHLDR RT WO | In distribution | |
| IF PAD HIP INTL | In distribution | |
| PAD INTELLI FLO KNEE COMPRESSION | In distribution | |
| PC GLACIER W/ M/U XL | In distribution | |
| PC CUBE W/ M/U XL LS WO | In distribution | |
| PAD INTELLI FLO ANKLE COMPRESSION | In distribution | |
| IF PAD ANKLE COMP INTL | In distribution | |
| NOVAPLUS PC CUBE W/ WO KNEE L | In distribution | |
| NOVAPLUS PC CUBE W/ WO M/U LS XL | In distribution | |
| IF PAD MU INTL | In distribution | |
| PAD RECT S | In distribution | |
| PAD INTELLI FLO MULTI USE | In distribution | |
| IF PAD MU LS INTL | In distribution | |
| PAD M/U XL | In distribution | |
| PC KODIAK COMBO IFP KNEE CMP | In distribution | |
| PAD INTELLI-FLO WRIST | In distribution | |
| NOVAPLUS POLAR PAD M/U | In distribution | |
| PC KODIAK COMBO IFP SHLDR | In distribution | |
| NOVAPLUS PC CUBE W/ WO SHLDR | In distribution | |
| PC CUBE W/ KNEE XL WO | In distribution | |
| PAD SHLDR WO | In distribution | |
| PAD SHLDR LT WO | Withdrawn | |
| WRAP BACK M | Withdrawn | |
| TOP SHELF KODIAK W/SHLDR | Withdrawn | |
| PAD SHLDR RT XL WO | Withdrawn | |
| WRAP ANKLE | Withdrawn | |
| PC GLACIER W/ ANKLE WO | Withdrawn | |
| WRAP HIP L | Withdrawn | |
| POLAR CARE Y ADAPTOR (6′) | Withdrawn | |
| AUTO ADAPTER COLD THERAPY | Withdrawn | |
| PAD M/U XL WO | Withdrawn | |
| TOP SHELF KODIAK | Withdrawn | |
| TOP SHELF KODIAK MU LS | Withdrawn | |
| PC GLACIER W/ HIP WO | Withdrawn | |
| WRAP HIP M | Withdrawn | |
| WRAP SHDLR S/M | Withdrawn | |
| TOP SHELF KODIAK W/MU | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 184 |
| Game Ready | Avanos Medical, Inc. | 101 |
| Donjoy | DJO, LLC | 72 |
| CTC-7 | Daesung Maref Co., Ltd. | 67 |
| Aircast | DJO, LLC | 63 |
| Youwen | Shanghai Youwen Medical Technology Co., Ltd. | 55 |
| Soft-Temp | Adroit Medical Systems, Inc. | 36 |
| ThermaZone | Innovative Medical Equipment | 27 |
| Cold Rush | Ossur Americas | 22 |
| Med4 Elite | Avanos Medical, Inc. | 20 |
| Cryopush | Chengdu Cryo-Push Medical Technology Co., Ltd. | 18 |
| Polar Products | Polar Products Inc | 18 |
Showing 12 of 153. All products under Pack, Hot Or Cold, Water Circulating
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K070402 | 2007-03-29 |
| K963596 | 1996-12-04 |
| K961855 | 1996-08-09 |
| K920581 | 1992-03-20 |
| K914434 | 1991-10-24 |
| K913729 | 1991-10-18 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-01-14 | Class II | Packaging | The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance. | 44,883 units | 2013-07-01 |
| 2013-01-14 | Class II | Packaging | The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance. | 44,883 units | 2013-07-01 |
| 2009-06-18 | Not classified | Employee error | Power supplies short-circuited at the electrical outlet upon initial use of the power supply, causing the circuit breaker for the electrical outlet to trip. | 20,439 | 2011-03-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.