ITS Model-L
Catalogue number ITSLC1711, ITSLC1721, listed by Inthesmart Co., Ltd., South Korea, under Camera, Cine, Endoscopic, Without Audio. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Anhui (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Fanxing Guangdian Medical Treatment Equipment Co Ltd | Beijing | Beijing | Contract manufacturer | 5 |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
| Tonglu Youshi Medical Instrument Co., Ltd. | Tonglu | Zhejiang | Manufacturer | 10 |
| Xuzhou Hengjia Electronic Technology Co., Ltd. | Xuzhou | Jiangsu | Manufacturer | 2 |
| Shenzhen Tuyou Medical Imaging Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Xuzhou AKX Electronic Science and Technology Co., Ltd. | Xuzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Inthesmart Co., Ltd., South Korea |
|---|---|
| FDA product code | FWL |
| Device type | Camera, Cine, Endoscopic, Without Audio |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-06-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ITSLC1711, ITSLC1721 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Accu-Beam | Transamerican Technologies International | 10 |
| Hayden Medical | Hayden Medical Inc | 4 |
| mytaMed | Mytamed, Inc. | 4 |
| Duroscope | FMD. Co., Ltd. | 3 |
| Firefly | Firefly Global | 2 |
| ITS Model-L6K | Inthesmart Co., Ltd. | 1 |
| Prosidio | Prosidio LLC | 1 |
| UnivLabs | Univlabs Technologies Private Limited | 1 |
| Health Support | Carolon Co. | 1 |
| Redfin | Firefly Global | 1 |
| FocESS | Stryker GmbH | 1 |
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.