Halter, Head, Traction
The Shoulder Table Chair Cups are used in conjunction with the Shoulder Table and provide stability for the head and chin during shoulder procedures.
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (2), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Changzhou Well Lands Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| A & I Industries Ltd | Foshan | Guangdong | Manufacturer | 35 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Shanghai NO. 2 Medical College Duhang Medical Equipment Factory | Shanghai | Shanghai | Contract manufacturer | 32 |
| Zhongshan A&E Machinery Industry Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 25 |
| Shenyang Ourpromise Medical Equipment Co., Ltd. | Shenyang | Liaoning | Manufacturer | 24 |
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | HSS |
| Device type | Halter, Head, Traction |
| Device class | Class 1 |
| Regulation | 21 CFR 888.5890 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-04-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| BF452 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 12 |
| Halter, Head, Traction | Zimmer Orthopaedic Surgical Products | 2 |
| Drive | Drive DeVilbiss Healthcare | 1 |
| Drivemedical | Drive DeVilbiss Healthcare | 1 |
| Disposable Head Halter | Mizuho Orthopedic Systems, Inc. | 1 |
| Assy, Head Halter and Chin Cup | Mizuho Orthopedic Systems, Inc. | 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.