DeRoyal
Prospera PRO NPWT Kit w/ Prospera Propel Technology
8manufacturers in China registered for this device type
34catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (2), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Shanghai ISO Medical Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 8 |
| Zhejiang Longterm Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 26 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Devon Medical Products (Jiangsu) Ltd | Nantong | Jiangsu | Repacker / relabeller | 12 |
| Nantong MedTech Medical Products Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 6 |
| Lightstone Medical Products (Ningbo) Co Ltd | Ningbo | Zhejiang | Specification developer | 3 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | OMP |
| Device type | Negative Pressure Wound Therapy Powered Suction Pump |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K162159 |
| Record published | 2017-08-15 |
| Record revised | 2023-10-09 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 10, case of 5, case of 40, case of 50, case of 100 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NP-1000M-US | In distribution | |
| NP-2000S | In distribution | |
| NP-2000 | In distribution | |
| NP-MINIKIT | In distribution | |
| NP-2000R-GPS2 | In distribution | |
| NSMNP-120-10 | In distribution | |
| NP-0506P | In distribution | |
| NP-8007K | In distribution | |
| NP-1004-10 | In distribution | |
| NP-0013P | In distribution | |
| NP-0507P | In distribution | |
| NP-6011P | In distribution | |
| NP-2000S-GPS1 | In distribution | |
| NP-2000DEMO | In distribution | |
| NP-8007S | In distribution | |
| NP-8007KG | In distribution | |
| NP-2000R-GPS1 | In distribution | |
| NSMNP-2000GPS | In distribution | |
| NP-3000EV | In distribution | |
| NP-2000LH | In distribution | |
| NP-1400-US | In distribution | |
| NP-0505P | In distribution | |
| NP-8007S-01 | In distribution | |
| NP-3000 | In distribution | |
| NP-300P | In distribution | |
| NP-1140-US | In distribution | |
| NP-2000GPS | In distribution | |
| 1-NP8045C | In distribution | |
| NP-6006U | In distribution | |
| NSMNP-120 | In distribution | |
| NP-0080P | In distribution | |
| NP-2000S-GPS2 | In distribution | |
| NP-2000EV | In distribution | |
| NP-1004 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 57 |
| Pico | Smith & Nephew, Inc. | 57 |
| Negative Pressure Wound Therapy Powered Suction Pump | Carilex Medical, Inc. | 43 |
| extriCARE | Oakwell Distribution, Inc. | 32 |
| Renasys | Smith & Nephew, Inc. | 27 |
| MicroDoc Npwt System | Pensar Medical | 26 |
| ExtriCARE | Alleva Medical Ltd | 22 |
| Vcare Alpha | I.V.T. Medical Ltd | 19 |
| V.A.C.® Granufoam™ | KCI USA, Inc. | 19 |
| Avance | Mölnlycke Health Care AB | 18 |
| Avance® Solo | Mölnlycke Health Care AB | 17 |
| Silverlon Antimicrobial Wound Dressing | Argentum Medical, LLC | 14 |
Showing 12 of 284. All products under Negative Pressure Wound Therapy Powered Suction Pump
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250586 | 2025-11-21 |
| K230233 | 2024-04-18 |
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.