Espire Elbow Hybrid
Espire Elbow Hybrid, Right, Black Carbon Finish, Lateral Dial, Standard, COAPT
47manufacturers in China registered for this device type
138catalogue numbers in this listing
1510(k) clearance
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.
| 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
| Listed by | College Park Industries, United States |
|---|---|
| FDA product code | GXY |
| Device type | Electrode, Cutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1320 |
| Establishment | Manufacturer |
| Record published | 2020-06-10 |
| Record revised | 2021-07-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2021-07-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EEH LJMS IBT | Withdrawn | |
| EEH RWLD CO | Withdrawn | |
| EEH LJLS CO | Withdrawn | |
| EEH R001MS | Withdrawn | |
| EEH RWLD IBT | Withdrawn | |
| EEH R001LS IBT | Withdrawn | |
| EEH RSMS | Withdrawn | |
| EEH RJLD CO | Withdrawn | |
| EEH L001LS CO | Withdrawn | |
| EEH LSLS IBT | Withdrawn | |
| EEH LCMD | Withdrawn | |
| EEH LSLD CO | Withdrawn | |
| EEH RBLD | Withdrawn | |
| EEH LSMS IBT | Withdrawn | |
| EEH R001MD IBT | Withdrawn | |
| EEH LBMD IBT | Withdrawn | |
| EEH RJLD | Withdrawn | |
| EEH R001LD | Withdrawn | |
| EEH L001LD | Withdrawn | |
| EEH RSLD IBT | Withdrawn | |
| EEH LSMS | Withdrawn | |
| EEH RBMD IBT | Withdrawn | |
| EEH LSLS CO | Withdrawn | |
| EEH LSMS CO | Withdrawn | |
| EEH RSMD | Withdrawn | |
| EEH LCLD CO | Withdrawn | |
| EEH RSMD CO | Withdrawn | |
| EEH L001MD IBT | Withdrawn | |
| EEH LBMS IBT | Withdrawn | |
| EEH LCLS CO | Withdrawn | |
| EEH LWLS IBT | Withdrawn | |
| EEH RBLS CO | Withdrawn | |
| EEH LWMD CO | Withdrawn | |
| EEH RBLS | Withdrawn | |
| EEH RJMS | Withdrawn | |
| EEH R001MS CO | Withdrawn | |
| EEH RBLS IBT | Withdrawn | |
| EEH LJMS | Withdrawn | |
| EEH LSMD IBT | Withdrawn | |
| EEH LCLD IBT | Withdrawn | |
| EEH L001MS CO | Withdrawn | |
| EEH L001MS IBT | Withdrawn | |
| EEH RWMS | Withdrawn | |
| EEH LWLS CO | Withdrawn | |
| EEH RBMS CO | Withdrawn | |
| EEH RSLS IBT | Withdrawn | |
| EEH RCMD | Withdrawn | |
| EEH LWMD | Withdrawn | |
| EEH RWLD | Withdrawn | |
| EEH LBMD CO | Withdrawn | |
| EEH RJLS IBT | Withdrawn | |
| EEH L001MD CO | Withdrawn | |
| EEH LCLD | Withdrawn | |
| EEH RBMD | Withdrawn | |
| EEH LWMS CO | Withdrawn | |
| EEH RWLS CO | Withdrawn | |
| EEH LCMD CO | Withdrawn | |
| EEH L001MS | Withdrawn | |
| EEH LCMS IBT | Withdrawn | |
| EEH RCMS CO | Withdrawn | |
| EEH LBLD IBT | Withdrawn | |
| EEH R001LS CO | Withdrawn | |
| EEH RJMD | Withdrawn | |
| EEH LBLD | Withdrawn | |
| EEH R001MD | Withdrawn | |
| EEH LBLS CO | Withdrawn | |
| EEH LWLD IBT | Withdrawn | |
| EEH LJMD IBT | Withdrawn | |
| EEH RSLS | Withdrawn | |
| EEH RSLD CO | Withdrawn | |
| EEH RCLD CO | Withdrawn | |
| EEH RSMD IBT | Withdrawn | |
| EEH LJLD CO | Withdrawn | |
| EEH LSMD CO | Withdrawn | |
| EEH RBMD CO | Withdrawn | |
| EEH LCLS | Withdrawn | |
| EEH L001LD IBT | Withdrawn | |
| EEH RWMS IBT | Withdrawn | |
| EEH RCLS CO | Withdrawn | |
| EEH LSLD IBT | Withdrawn | |
| EEH LJMD | Withdrawn | |
| EEH RSMS CO | Withdrawn | |
| EEH RWLS | Withdrawn | |
| EEH L001MD | Withdrawn | |
| EEH LJLS IBT | Withdrawn | |
| EEH LJLD | Withdrawn | |
| EEH RJLS | Withdrawn | |
| EEH LBLD CO | Withdrawn | |
| EEH RJMD IBT | Withdrawn | |
| EEH LBMD | Withdrawn | |
| EEH RCLS IBT | Withdrawn | |
| EEH RCMD IBT | Withdrawn | |
| EEH L001LS | Withdrawn | |
| EEH RJLS CO | Withdrawn | |
| EEH R001LD IBT | Withdrawn | |
| EEH RWMS CO | Withdrawn | |
| EEH LCMD IBT | Withdrawn | |
| EEH R001LD CO | Withdrawn | |
| EEH LBMS CO | Withdrawn | |
| EEH LWLD CO | Withdrawn | |
| EEH RCLD IBT | Withdrawn | |
| EEH LWLS | Withdrawn | |
| EEH RJMD CO | Withdrawn | |
| EEH RJMS IBT | Withdrawn | |
| EEH LSLD | Withdrawn | |
| EEH RCLS | Withdrawn | |
| EEH LJLD IBT | Withdrawn | |
| EEH RCLD | Withdrawn | |
| EEH RBMS | Withdrawn | |
| EEH RBMS IBT | Withdrawn | |
| EEH RSLD | Withdrawn | |
| EEH RCMS | Withdrawn | |
| EEH L001LD CO | Withdrawn | |
| EEH R001LS | Withdrawn | |
| EEH LWMD IBT | Withdrawn | |
| EEH LSMD | Withdrawn | |
| EEH LCLS IBT | Withdrawn | |
| EEH RWMD IBT | Withdrawn | |
| EEH RCMD CO | Withdrawn | |
| EEH LCMS | Withdrawn | |
| EEH RSMS IBT | Withdrawn | |
| EEH LBLD IBT | Withdrawn | |
| EEH LJMD CO | Withdrawn | |
| EEH LCMS CO | Withdrawn | |
| EEH L001LS IBT | Withdrawn | |
| EEH LJMS CO | Withdrawn | |
| EEH RBLD IBT | Withdrawn | |
| EEH RWMD CO | Withdrawn | |
| EEH LSLS | Withdrawn | |
| EEH RWMD | Withdrawn | |
| EEH LWMS IBT | Withdrawn | |
| EEH RJLD IBT | Withdrawn | |
| EEH RSLS CO | Withdrawn | |
| EEH RJMS CO | Withdrawn | |
| EEH LJLS | Withdrawn | |
| EEH RBLD CO | Withdrawn | |
| EEH LWLD | Withdrawn | |
| EEH RCMS IBT | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rhythmlink® | Rhythmlink International, LLC | 455 |
| waveguard | Eemagine Medical Imaging Solutions Gmbh | 166 |
| 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 |
| Natus | Natus Neurology Incorporated | 66 |
Showing 12 of 1,006. All products under Electrode, Cutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182757 | 2018-11-29 |
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.