The PPS is a length of black neoprene which is bonded between two polyester layers. The top layer is made from knitted 100% Polyester, which is colored either yellow for the standard PPS,…
The PPS is a length of black neoprene which is bonded between two polyester layers. The top layer is made from knitted 100% Polyester, which is colored either yellow for the standard PPS, or dark green for the tactical version of the PPS. The bottom layer is also 100% polyester but is colored black for both the standard and the tactical PPS and has a velour finish so is glossy in appearance. The PPS also features two identical 100% nylon belts (blue for the PPS, or black for the tactical version of the PPS), each with a square tab at one end and a triangular anchor at the other. The tab and anchor both feature 100% nylon hook material on the inner surface so allow adherence to the knitted polyester layer on the neoprene. The two identical 100% nylon belts are thread through a 100% nylon tri-glide buckle (black). The PPS is intended for the emergency management of suspected pelvic fracture(s).
Who Else Makes It
Concentrated in Jiangsu (2), Hebei (2), Guangdong (1).
Record
Regulatory record for Prometheus Pelvic Splint | Listed by | Safeguard Medical Technologies Ltd, United Kingdom |
| FDA product code | HSQ |
| Device type | Belt, Pelvic, Traction |
| Device class | Class 1 |
| Regulation | 21 CFR 888.5890 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-10-27 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
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.