Alpha

Alpha Control Liner System Kit Extra Small, 10 cm Leads

Registry build 21.09.26
47manufacturers in China registered for this device type
68catalogue 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 Alpha
Listed by WillowWood Global LLC, United States
FDA product code GXY
Device type Electrode, Cutaneous
Device class Class 2
Regulation 21 CFR 882.1320
Establishment Repacker / relabeller, Manufacturer
510(k) K223738
Record published 2025-03-20

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries serial number

Catalogue Numbers

Catalogue numbers for Alpha
Catalogue number Size Status
ACL-049-X18 In distribution
ACL-049-M10 In distribution
ACLS-049-M14 In distribution
ACLS-049-S06 In distribution
ACLS-049-X10 In distribution
ACLS-049-S22 In distribution
ACL-049-XF In distribution
ACLS-049-X16 In distribution
ACL-049-S14 In distribution
ACL-049-X06 In distribution
ACL-049-S06 In distribution
ACL-049-M04 In distribution
ACL-049-M08 In distribution
ACL-304 In distribution
ACL-049-S16 In distribution
ACL-049-X04 In distribution
ACL-049-S20 In distribution
ACL-049-X10 In distribution
ACL-049-M12 In distribution
ACL-049-M22 In distribution
ACLS-049-M18 In distribution
ACLS-049-X18 In distribution
ACLS-049-X14 In distribution
ACL-049-X12 In distribution
ACL-303 In distribution
ACLS-049-M16 In distribution
ACL-049-S04 In distribution
ACLS-049-S12 In distribution
ACL-302 In distribution
ACLS-049-X06 In distribution
ACL-049-M06 In distribution
ACL-049-S08 In distribution
ACL-049-X22 In distribution
ACL-049-S10 In distribution
ACL-049-S22 In distribution
ACL-049-S12 In distribution
ACL-049-X14 In distribution
ACLS-049-S20 In distribution
ACLS-049-X20 In distribution
ACLS-049-S08 In distribution
ACL-049-X16 In distribution
ACLS-049-X04 In distribution
ACL-049-M18 In distribution
ACL-049-M20 In distribution
ACL-049-M14 In distribution
ACL-049-MF In distribution
ACLS-049-M08 In distribution
ACL-049-S18 In distribution
ACL-049-SF In distribution
ACLS-049-M22 In distribution
ACLS-049-S18 In distribution
ACLS-049-S14 In distribution
ACLS-049-M04 In distribution
ACLS-049-S04 In distribution
ACL-049-X20 In distribution
ACL-049-X08 In distribution
ACL-300 In distribution
ACLS-049-X12 In distribution
ACLS-049-M06 In distribution
ACLS-049-M10 In distribution
ACLS-049-X22 In distribution
ACL-301 In distribution
ACLS-049-M12 In distribution
ACLS-049-S16 In distribution
ACLS-049-M20 In distribution
ACLS-049-X08 In distribution
ACL-049-M16 In distribution
ACLS-049-S10 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
Espire Elbow Pro College Park Industries 67
Natus Natus Neurology Incorporated 66

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