Thermophore Pro
Catalogue number F00395, listed by Battle Creek Equipment, United States, under Pad, Heating, Powered. 144 manufacturers in China are registered for this product 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 | Battle Creek Equipment, United States |
|---|---|
| FDA product code | IRT |
| Device type | Pad, Heating, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5740 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-01-04 |
| Record revised | 2020-07-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
| Packaging | Case pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F00395 | 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 |
| Homedics | FKA Distributing Co., LLC | 34 |
| 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 |
Showing 12 of 165. All products under Pad, Heating, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K851237 | 1985-07-29 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2016-09-15 | Class II | Device Design | Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns. | 99,060 | 2018-01-11 |
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.