AeroDVx ™

The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pneumatic pump and hand pump to provide static and/or intermittent pneumatic compression for…

Registry build 21.09.26

The AeroDVx ™ System is comprised of a gradient compression sleeve, electronic intermittent pneumatic pump and hand pump to provide static and/or intermittent pneumatic compression for compression therapy or DVT Prophylaxis. The AeroDVx™ gradient compression sleeve is composed of a family of non-sterile single patient use medical devices. The AeroDVx ™ Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s leg. The AeroDVx ™ Gradient Compression Sleeve is available in four sizes and two different lengths (standard and short). The wrap is composed of two polyurethane laminates that are sealed together creating an internal bladder system. The bladder system contains circular and bar welds that were engineered with their spacing and location to provide gradient compression profile when worn and inflated. An inflation source is attached to the inflation valve on the sleeve. The insertion of the inflation source onto the check valve of pressure opens the leur valve so that the bladder can be inflated or deflated based on the direction of airflow. There will be two inflation sources provided: a portable, battery-operated intermittent pneumatic pump, the AeroDVx™ Pump, to provide intermittent pneumatic compression and a hand pump to provide static compression. The system is intended for hospital and outpatient use.

24manufacturers in China registered for this device type
16catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (10), Jiangsu (7), Zhejiang (4). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JOW
Manufacturer City Province Registered as Device types
Ningbo MPF Manufacturing Co., Ltd. Ningbo Zhejiang Contract manufacturer 35
JKH Health Co., Ltd. Dongguan Guangdong Contract manufacturer 22
Jiangsu Reak Healthy Articles Co., Ltd. Yangzhong Jiangsu Contract manufacturer 18
Ningbo Albert Novosino Co., Ltd. Yuyao Zhejiang Contract manufacturer 17
Shenzhen Homed Medical Device Co Ltd Shenzhen Guangdong Contract manufacturer 13
Alleva Medical (D.G.) Ltd Dongguan Guangdong Contract manufacturer 13
Xiamen Weiyou Intelligent Technology Co., Ltd. Xiamen Fujian Contract manufacturer 9
Suzhou Minhua Medical Equipment Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Grandway Technology (Shenzhen) Limited Shenzhen Guangdong Contract manufacturer 6
Shanghai Caremate Medical Device Co., Ltd. Shanghai Shanghai Contract manufacturer 6
Dongguan Esino Manufacturing Service Co., Ltd. Dongguan Guangdong Contract manufacturer 4
MedHealth Medical Limited Shenzhen Guangdong Contract manufacturer 2

Showing 12 of 24. All 24 manufacturers in China registered for Sleeve, Limb, Compressible

Record

Regulatory record for AeroDVx ™
Listed by SUN-Scientific Inc., United States
FDA product code JOW
Device type Sleeve, Limb, Compressible
Device class Class 2
Regulation 21 CFR 870.5800
Establishment Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer
510(k) K183349
Record published 2019-11-05

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number
Distribution end date 2030-10-31

Catalogue Numbers

Catalogue numbers for AeroDVx ™
Catalogue number Size Status
Extra Large,Unilateral In distribution
Small,Unilateral In distribution
Medium, Short, Unilateral In distribution
Large, Bilateral In distribution
Large, Short, Bilateral In distribution
Small, Short, Bilateral In distribution
Medium,Short, Bilateral In distribution
Medium, Unilateral In distribution
Medium, Bilateral In distribution
Extra Large, Short, Unilateral In distribution
Large, Short, Unilateral In distribution
Extra Large, Bilateral In distribution
Extra Large, Short, Bilateral In distribution
Large, Unilateral In distribution
Small, Short, Unilateral In distribution
Small, Bilateral In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Flexitouch Plus Tactile Systems Technology Inc 151
Flexitouch Tactile Systems Technology Inc 138
Sleeve, Limb, Compressible Stryker Sustainability Solutions 113
Airos Airos Medical Inc 101
Medline Medline Industries, Inc. 97
Kendall SCD Cardinal Health 73
Wright Wright Therapy Products, Inc. 72
ACTitouch Tactile Systems Technology Inc 70
Medline ReNewal Medline Industries, Inc. 65
Koya Medical Koya Medical, Inc. 61
Aircast DJO, LLC 60
Hydroven Huntleigh Healthcare Ltd. 49

Showing 12 of 363. All products under Sleeve, Limb, Compressible

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K222823 2023-09-07
K183349 2019-07-19

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