Alloy Melter
12 quart, 230V
78manufacturers in China registered for this device type
4catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (19), Jiangsu (13), Guangdong (10). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Jiangsu Hanheng Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 20 |
| Honghu Danielle Sanitary Material Co., Ltd. | Honghu | Hubei | Contract manufacturer | 12 |
| Primed Liyang Medical Products Manufacturing Co., Ltd. | Liyang | Jiangsu | Contract manufacturer | 11 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Gushi priMED Medical Products Manufacturing Co., Ltd. | Gushi County | Henan | Contract manufacturer | 9 |
| Wenzhou Weilan Optical Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 8 |
| priMED Jiujiang Medical Products Manufacturing Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 7 |
| Skytech Electronics (HK) Limited | Tsim Sha Tsui | Hong Kong | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
Showing 12 of 78. All 78 manufacturers in China registered for Shield, Protective, Personnel
Record
| Listed by | Medtec LLC, United States |
|---|---|
| FDA product code | KPY |
| Device type | Shield, Protective, Personnel |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-06-14 |
| Record revised | 2020-07-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Width 13.05 to 17.95 in; length 14.87 to 17.868 in |
| Distribution end date | 2023-06-26 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MT803DEX | Width 17.95 in | Withdrawn |
| MT801.5D | Width 13.05 in | Withdrawn |
| MT803D | Length 17.868 in | Withdrawn |
| MT801.5DEX | Width 13.05 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kenex | Kenex (Electro-Medical) Ltd. | 163 |
| Bloxr | Bloxr Solutions LLC | 125 |
| Aadco | Aadco Medical, Inc. | 104 |
| UT | Mavig Gmbh | 87 |
| CAP | Burlington Medical, LLC | 66 |
| Radpad | Worldwide Innovations & Technologies, Inc. | 59 |
| AngioSystems SorbX | Angiosystems, Inc. | 52 |
| Sleeve | Burlington Medical, LLC | 51 |
| Lead Lined | Biodex Medical Systems, Inc. | 40 |
| Molded Products, Inc. | Molded Products Inc. | 34 |
| MasterPeace | Texray AB | 30 |
| Halyard Scatter Radiation Shields | Angiosystems, Inc. | 30 |
Showing 12 of 134. All products under Shield, Protective, Personnel
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K962622 | 1996-10-01 |
| K954456 | 1995-12-21 |
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.