PRO Pelvic Splint
PRO PELVIC SPLINT 1 ea - 6 mm Neoprene Band, 1 ea - Black Velcro Straps with Buckle Intended for the emergency management of suspected pelvic fracture(s).
5manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Hebei (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yearstar Healthcare Technology Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 43 |
| Hengshui Jingkang Medical Device Co., Ltd. | Hengshui | Hebei | Manufacturer | 31 |
| ZJG Royaltrust MED Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 28 |
| Anping Guardian Medical Equipment Co., Ltd. | Hengshui | Hebei | Manufacturer | 23 |
| Dongguan Ness Sports Technology Co., Ltd. | Dongguan | Guangdong | Manufacturer | 10 |
Record
| Listed by | Safeguard US Operating, LLC, United States |
|---|---|
| FDA product code | HSQ |
| Device type | Belt, Pelvic, Traction |
| Device class | Class 1 |
| Regulation | 21 CFR 888.5890 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-02-19 |
| Record revised | 2023-01-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02 | In distribution | |
| 01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prometheus Pelvic Splint – Case of 40pcs | Safeguard Medical Technologies Ltd | 1 |
| Prometheus Pelvic Splint (Tactical) | Safeguard Medical Technologies Ltd | 1 |
| Prometheus Pelvic Splint | Safeguard Medical Technologies Ltd | 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.