Espire Elbow Pro
Espire Elbow Pro, Left, Black Carbon Finish, Standard, COAPT
47manufacturers in China registered for this device type
67catalogue 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 | 2020-07-07 |
| Record revised | 2021-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | expiry date, manufacturing date, serial number |
| Distribution end date | 2021-07-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EEP RCD IBT | Withdrawn | |
| EEP LWD | Withdrawn | |
| EEP RCD | Withdrawn | |
| EEP LWS CO | Withdrawn | |
| EEP LJS | Withdrawn | |
| EEP RWD IBT | Withdrawn | |
| EEP LJS IBT | Withdrawn | |
| EEP RSS CO | Withdrawn | |
| EEP LSD CO | Withdrawn | |
| EEP RSD CO | Withdrawn | |
| EEP LWD CO | Withdrawn | |
| EEP LCD | Withdrawn | |
| EEP RJD IBT | Withdrawn | |
| EEP LCD IBT | Withdrawn | |
| EEP LWS | Withdrawn | |
| EEP LBD IBT | Withdrawn | |
| EEP LWD IBT | Withdrawn | |
| EEP L001S IBT | Withdrawn | |
| EEP RBS CO | Withdrawn | |
| EEP LCD CO | Withdrawn | |
| EEP L001D CO | Withdrawn | |
| EEP LCS CO | Withdrawn | |
| EEP RSS IBT | Withdrawn | |
| EEP LSS CO | Withdrawn | |
| EEP RJS IBT | Withdrawn | |
| EEP R001S CO | Withdrawn | |
| EEP RJD | Withdrawn | |
| EEP RBD CO | Withdrawn | |
| EEP R001S | Withdrawn | |
| EEP LBD | Withdrawn | |
| EEP RSS | Withdrawn | |
| EEP RWS CO | Withdrawn | |
| EEP RSD IBT | Withdrawn | |
| EEP RCS | Withdrawn | |
| EEP LBS | Withdrawn | |
| EEP RWS | Withdrawn | |
| EEP RWS IBT | Withdrawn | |
| EEP L001S | Withdrawn | |
| EEP LBS IBT | Withdrawn | |
| EEP LJS CO | Withdrawn | |
| EEP RWD | Withdrawn | |
| EEP LJD CO | Withdrawn | |
| EEP RWD CO | Withdrawn | |
| EEP LWS IBT | Withdrawn | |
| EEP LSD | Withdrawn | |
| EEP LSS | Withdrawn | |
| EEP RBS IBT | Withdrawn | |
| EEP RBS | Withdrawn | |
| EEP RCD CO | Withdrawn | |
| EEP RCS CO | Withdrawn | |
| EEP LJD | Withdrawn | |
| EEP L001S CO | Withdrawn | |
| EEP LSS IBT | Withdrawn | |
| EEP R001S IBT | Withdrawn | |
| EEP LBD CO | Withdrawn | |
| EEP RCS IBT | Withdrawn | |
| EEP LCS | Withdrawn | |
| EEP RJS CO | Withdrawn | |
| EEP LJD IBT | Withdrawn | |
| EEP LSD IBT | Withdrawn | |
| EEP RBD | Withdrawn | |
| EEP LBS CO | Withdrawn | |
| EEH LBLS | Withdrawn | |
| EEP L001D IBT | Withdrawn | |
| EEP R001D IBT | Withdrawn | |
| EEP RJS | Withdrawn | |
| EEP L001D | Withdrawn |
Same 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 |
| 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.