What is FDA product code OMP?

For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

WoundPro Control Unit · Negative Pressure Wound Therapy Powered Suction Pump → General & Plastic Surgery

Name: WoundPro Control Unit
Brand: WoundPro Control Unit

8manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

1recall

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.

Chinese manufacturers registered for FDA product code OMP
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

Regulatory record for WoundPro Control Unit
Listed by	Pensar Medical, 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	Specification developer, Manufacturer
510(k)	K150960
Record published	2022-10-07

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number
Packaging	Box

Catalogue Numbers

Catalogue numbers for WoundPro Control Unit
Catalogue number	Size	Status
8463540 0181		In distribution

Same Product Code

Other products under the same FDA 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
DeRoyal	Deroyal Industries, Inc.	34
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

Showing 12 of 284. All products under Negative Pressure Wound Therapy Powered Suction Pump

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K200223	2020-10-23
K150960	2016-12-01

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2012-08-31	Class II	Device Design	Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit’s display screen.	919 units	2017-12-27

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.

WoundPro Control Unit