Avacen
The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME XL is designed to comfortably and noninvasively…
The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME XL is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN HOME XL for approximately 10 to 60 minutes per treatment session. A vacuum pump creates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat.
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 | Avacen, Inc., United States |
|---|---|
| FDA product code | IRT |
| Device type | Pad, Heating, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5740 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K133981 |
| Record published | 2019-12-31 |
| Record revised | 2023-03-13 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | serial number |
| Storage | Storage environment temperature 32 to 140 °F; Storage environment temperature 0 to 60 °C; Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 500 to 1060 millibar |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AVACEN HOME+ | In distribution | |
| AVACEN HOME XL 3-YEAR | In distribution | |
| AVACEN HOME | In distribution | |
| AVACEN HOME XL 5-YEAR | In distribution | |
| POP-ON/POP-OFF CUFF | In distribution | |
| AVACEN HOME+ 5-YEAR | In distribution | |
| VCI | In distribution | |
| 25-pack Mitts | In distribution | |
| HOME XL | In distribution | |
| 100-pack Mitts | 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 |
|---|---|
| K133981 | 2014-08-15 |
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.