Homedics
Weighted GEL Heating PAD - 12" X 15"
144manufacturers in China registered for this device type
34catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Concentrated in Guangdong (69), Zhejiang (25), Jiangsu (11). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 30 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Dongguan Yingfeng Metal & Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Aopu Lighting (Jinyun) Co., Ltd. | Lishui | Zhejiang | Contract manufacturer | 9 |
| Shenzhen Xiangzhida Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Jiangsu Alphay Medical Device Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 6 |
| Shanghai GK Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Zhongshan GL Electronics Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 5 |
| Xiamen Ubest Electronic Technology Co., Ltd. | Xiameng | Fujian | Contract manufacturer | 3 |
| Eagle Electric(Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Ezra Innovation (Dong guan) Limited | Dongguan | Guangdong | Contract manufacturer | 2 |
Showing 12 of 144. All 144 manufacturers in China registered for Pad, Heating, Powered
Record
| Listed by | FKA Distributing Co., LLC, United States |
|---|---|
| FDA product code | IRT |
| Device type | Pad, Heating, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5740 |
| Establishment | Repacker / relabeller, Complaint-file establishment |
| Premarket notification | Exempt |
| Record published | 2021-05-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HP-21DKJ-BR | In distribution | |
| SP-252HJ | In distribution | |
| HP-GW45DSJ | In distribution | |
| SPE-DOT100HJ | In distribution | |
| HP-W34DLJ-GY | In distribution | |
| HP-G51DKJ | In distribution | |
| HP-24DOJ-GY | In distribution | |
| HPM-27AJ-NV | In distribution | |
| HP-W32DMJ-BG | In distribution | |
| SR-CMC5SHJ | In distribution | |
| HP-25AJ-NV | In distribution | |
| HP-24AOJ-GY | In distribution | |
| HP-G44DJ | In distribution | |
| SR-CMXC5SHJ | In distribution | |
| HP-22ASJ-BG | In distribution | |
| HP-GW46DMJ | In distribution | |
| HP-W32AMJ-BG | In distribution | |
| HP-23DKJ-TE | In distribution | |
| HP-G50DSJ-2 | In distribution | |
| HP-G54DJ | In distribution | |
| SR-CMX5SJ | In distribution | |
| HP-20DSJ-BL | In distribution | |
| HP-10ASJ-GY | In distribution | |
| HCS-50DJ-BK | In distribution | |
| SPEDOT200HJQ8SH | In distribution | |
| HP-W34ALJ-GY | In distribution | |
| HP-G50DSJ | In distribution | |
| HP-15AKJ-NV | In distribution | |
| HP-W30ASJ-NV | In distribution | |
| HP-21AKJ-BR | In distribution | |
| HPM-W36ALJ-BL | In distribution | |
| HP-G41DKJ | In distribution | |
| HP-20ASJ-BL | In distribution | |
| HP-G40DSJ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sunbeam | Jarden Consumer Solutions | 182 |
| UTK | UTK Technology(Shenzhen)Limited | 66 |
| Pure Enrichment | Bear Down Consulting | 62 |
| HealthyLine | Imedia NY Inc | 55 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 28 |
| Thermophore | Battle Creek Equipment | 23 |
| Renpho Heating Pad | Joicom Corporation | 22 |
| Walgreens | Walgreen Co. | 21 |
| Sharper Image | Zhejiang Lumeng Health & Technology Co., Ltd. | 20 |
| SpeedHeat | Inspiration Medical Technology, Inc. | 19 |
| Venture Heat | Matsum Inc | 18 |
| Heating Pad | Ningbo Kangheng Appliance Co., Ltd. | 14 |
Showing 12 of 165. All products under Pad, Heating, Powered
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-02-09 | Not classified | Other | Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage. | 292,108 of all models | 2010-01-04 |
| 2007-02-09 | Not classified | Other | Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage. | 292,108 of all models | 2010-01-04 |
| 2007-02-09 | Not classified | Other | Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage. | 292,108 of all models | 2010-01-04 |
| 2007-02-09 | Not classified | Other | Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage. | 292,108 of all models | 2010-01-04 |
| 2007-02-09 | Not classified | Other | Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage. | 292,108 of all models | 2010-01-04 |
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.