Resorb X
Xcelsior Water Bath, Water Container
19manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (13), Jiangsu (2), Henan (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Tutamen Metalwork Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 12 |
| Tianjin Zhengtian Medical Instrument Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 2 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Picard Healthcare Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
| Dongguan Quanding Medical Supplies Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen Obestec Industrial Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 14 |
| Shenzhen Joose Beauty Electronic Co., Ltd. | Shen Zhen | Guangdong | Contract manufacturer | 13 |
| Linjiang (Holdings) Limited | Shangqiu | Henan | Private-label distributor | 11 |
| Zhongshan Kingdom Electrical Appliance Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 11 |
| Shenzhen Youmay Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
| Zhongshan Bisen Plastic Electronic Products Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 9 |
Showing 12 of 19. All 19 manufacturers in China registered for Unit, Heating, Powered
Record
| Listed by | KLS-Martin L.P., United States |
|---|---|
| FDA product code | IRQ |
| Device type | Unit, Heating, Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5950 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-06-19 |
| Record revised | 2024-08-27 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 52-400-13-04 | In distribution | |
| 52-400-98-04 | In distribution | |
| 52-400-14-04 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HydraTherm | Drive DeVilbiss Healthcare | 93 |
| Whitehall Thermalators | Whitehall Manufacturing Co | 91 |
| Thermasplint | Whitehall Manufacturing Co | 64 |
| Chattanooga | DJO, LLC | 27 |
| Moist Hot-Pack Unit | Karis Co., Ltd. | 16 |
| Lotion/Gel Warmer | Drive DeVilbiss Healthcare | 6 |
| Delta | Stryker Leibinger Gmbh & Co. KG | 5 |
| Inion® Universal instruments | Inion OY | 4 |
| Soqi | Hsin TEN Health & Wealth INDUSTRY(HEFEI)Co., Ltd. | 4 |
| Vadi | Vadi Medical Technology Co., Ltd. | 3 |
| Level ONE | KLS-Martin L.P. | 2 |
| Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2 |
Showing 12 of 28. All products under Unit, Heating, Powered
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.