Prometheus Pelvic Splint – Case of 40pcs

A case of 40 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…

Registry build 21.09.26

A case of 40 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).

5manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (2), Hebei (2), Guangdong (1).

Chinese manufacturers registered for FDA product code HSQ
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

Regulatory record for Prometheus Pelvic Splint – Case of 40pcs
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

Catalogue Numbers

Catalogue numbers for Prometheus Pelvic Splint – Case of 40pcs
Catalogue number Size Status
PRO400 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
PRO Pelvic Splint Safeguard US Operating, LLC 2
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer