Jiajian

Flexible and easy to fit electrode can be applied to every contour of the human body. You can use the electrodes many times because of its reliable long lasting gel. 2 Electrodes in sealed…

Registry build 21.09.26

Flexible and easy to fit electrode can be applied to every contour of the human body. You can use the electrodes many times because of its reliable long lasting gel. 2 Electrodes in sealed foil pouch.

47manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (29), Jiangsu (4), Zhejiang (4). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GXY
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Shenzhen Konmed Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
China Qingdao Bright Medical Manufacturing Co., Ltd. Qingdao Shandong Contract manufacturer 8
Pine Moon Electronics Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Top-rank Health Care Co., Ltd. Shaoxing Zhejiang Contract manufacturer 7
Omron (Dalian) Co., Ltd. (Plant 1) Dalian Liaoning Contract manufacturer 7
Shenzhen Zifound Infonet Technology Co., Ltd. Shenzhen, Guandong Guangdong Contract manufacturer 2
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Shenzhen Guangdong Specification developer 61
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56
Beijing Choice Electronic Technololgy Co., Ltd. Beijing Beijing Repacker / relabeller 30
Taizhou Chenguang Import AND Export Trading Co., Ltd. Taizhou Jiangsu Exporter 25

Showing 12 of 47. All 47 manufacturers in China registered for Electrode, Cutaneous

Record

Regulatory record for Jiajian
Listed by Wuxi Jiajian Medical Instrument Co., Ltd., China
FDA product code GXY
Device type Electrode, Cutaneous
Device class Class 2
Regulation 21 CFR 882.1320
Establishment Contract manufacturer, Manufacturer, Exporter
510(k) K090198
Record published 2019-07-02

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, expiry date, manufacturing date
Packaging Pack of 800, carton of 20, box of 50

Catalogue Numbers

Catalogue numbers for Jiajian
Catalogue number Size Status
50*50mm In distribution
50*130mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Rhythmlink® Rhythmlink International, LLC 455
waveguard Eemagine Medical Imaging Solutions Gmbh 166
Espire Elbow Hybrid College Park Industries 138
Technomed Europe Technomed Engineering B.V. 126
Cadwell Technomed Engineering B.V. 111
The Electrode Store Impulse Technology LLC 109
Electrode, Cutaneous Gmdasz Manufacturing Co., Ltd. 99
Auvon Shenzhen Yuwen E-Commerce Co., Ltd. 93
AdvanTrode Pepin Manufacturing, Inc. 78
Uni-Patch Cardinal Health 77
Alpha WillowWood Global LLC 68
Espire Elbow Pro College Park Industries 67

Showing 12 of 1,006. All products under Electrode, Cutaneous

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K192568 2021-02-03
K090198 2009-06-23

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