Pohaku

Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be…

Registry build 21.09.26

Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use. Adhesive electrodes are intended for use

47manufacturers in China registered for this device type
6catalogue numbers in this listing

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 Pohaku
Listed by Shenzhen Damiti Technology Co., Ltd.
FDA product code GXY
Device type Electrode, Cutaneous
Device class Class 2
Regulation 21 CFR 882.1320
Record published 2020-03-18
Record revised 2021-02-19 (version 2)

Specifications

Specifications
MRI safety MR Safe
Supplied sterile Yes
Single use Yes
Over the counter Yes
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date, serial number
Packaging Pack of 80, carton box of 80

Catalogue Numbers

Catalogue numbers for Pohaku
Catalogue number Size Status
PKEB1520024 In distribution
AS0505-P-W In distribution
PK1520023 In distribution
AS0510-P-B In distribution
AS0510-P-W In distribution
AS0505-P-B 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

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