Breg
1 Ice Water Container, 1 12 VDC, 24W output 100-240V 50/60 Hz input transformer and 2 Sequential Calf Pads
24manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (10), Jiangsu (7), Zhejiang (4). 14 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 |
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Jiangsu Reak Healthy Articles Co., Ltd. | Yangzhong | Jiangsu | Contract manufacturer | 18 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Shenzhen Homed Medical Device Co Ltd | Shenzhen | Guangdong | Contract manufacturer | 13 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Xiamen Weiyou Intelligent Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
| Suzhou Minhua Medical Equipment Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Grandway Technology (Shenzhen) Limited | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Shanghai Caremate Medical Device Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 6 |
| Dongguan Esino Manufacturing Service Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| MedHealth Medical Limited | Shenzhen | Guangdong | Contract manufacturer | 2 |
Showing 12 of 24. All 24 manufacturers in China registered for Sleeve, Limb, Compressible
Record
| Listed by | Breg, Inc., United States |
|---|---|
| FDA product code | JOW |
| Device type | Sleeve, Limb, Compressible |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K122640 |
| Record published | 2016-08-15 |
| Record revised | 2023-08-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2023-08-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VPULSE THERM COMP PAD UNIV | In distribution | |
| VPULSE W SEQ COMP PADS (2) | In distribution | |
| VPULSE SEQ COMP PAD (2) | In distribution | |
| VPULSE THERM COMP PAD BACK | In distribution | |
| VPULSE THERM COMP PAD HIP | In distribution | |
| VPULSE THERM COMP PAD FT/ANKL | In distribution | |
| DVT GUARDIAN | In distribution | |
| VPULSE THERM COMP PAD BACK NO LNR | In distribution | |
| VPULSE THERM COMP PAD SHLDR | In distribution | |
| VPULSE THERM COMP PAD KNEE | In distribution | |
| VPULSE THERM COMP PAD KNEE L | In distribution | |
| VPULSE W/O PADS | In distribution | |
| VPULSE THERM PAD ANKL | Withdrawn | |
| VPULSE THRM CMP PAD KNEE L NO LNR | Withdrawn | |
| VPULSE THERM CMP PAD HIP NO LNR | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Flexitouch Plus | Tactile Systems Technology Inc | 151 |
| Flexitouch | Tactile Systems Technology Inc | 138 |
| Sleeve, Limb, Compressible | Stryker Sustainability Solutions | 113 |
| Airos | Airos Medical Inc | 101 |
| Medline | Medline Industries, Inc. | 97 |
| Kendall SCD | Cardinal Health | 73 |
| Wright | Wright Therapy Products, Inc. | 72 |
| ACTitouch | Tactile Systems Technology Inc | 70 |
| Medline ReNewal | Medline Industries, Inc. | 65 |
| Koya Medical | Koya Medical, Inc. | 61 |
| Aircast | DJO, LLC | 60 |
| Hydroven | Huntleigh Healthcare Ltd. | 49 |
Showing 12 of 363. All products under Sleeve, Limb, Compressible
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.