Chalgren
Reusable Disc Electrodes, EEG, 10mm Silver Plated Discs, 120 inch Coated Leadwire (Assorted Colors)
47manufacturers in China registered for this device type
58catalogue numbers in this listing
8510(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.
| 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 | Chalgren Enterprises, Inc., United States |
|---|---|
| FDA product code | GXY |
| Device type | Electrode, Cutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1320 |
| 510(k) | K953356 |
| Record published | 2016-09-09 |
| Record revised | 2023-12-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 24 to 120 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 293-2SL-24TP | Length 24 in | In distribution |
| 445-10S-120TP | In distribution | |
| 445-10G-60PTP | Length 60 in | In distribution |
| 266-9G-24TP | Length 24 in | In distribution |
| 293-2SL-48STP | Length 48 in | In distribution |
| 445-10G-120PTP | In distribution | |
| 265-9S-24BTP | Length 24 in | In distribution |
| 266-9T-24TP | Length 24 in | In distribution |
| 285-32-24TP | Length 24 in | In distribution |
| 293-2-36STP | Length 36 in | In distribution |
| 293-2SL-36STP | Length 36 in | In distribution |
| 265-9S-24RTP | Length 24 in | In distribution |
| 265-9G-24RTP | Length 24 in | In distribution |
| 263-9P-24BTP | Length 24 in | In distribution |
| 444-10G-48TP | Length 48 in | In distribution |
| 264-9P-36STP | Length 36 in | In distribution |
| 266-9T-36STP | Length 36 in | In distribution |
| 295-2-48TP | Length 48 in | In distribution |
| 293-2-48STP | Length 48 in | In distribution |
| 445-10G-96TP | Length 96 in | In distribution |
| 285-32-48B | Length 48 in | In distribution |
| 295-2-24TP | Length 24 in | In distribution |
| 444-10S-96TP | Length 96 in | In distribution |
| 445-10G-120PTP | Length 120 in | In distribution |
| 295-2-48STP | Length 48 in | In distribution |
| 265-9T-24BTP | Length 24 in | In distribution |
| 265-9T-24RTP | Length 24 in | In distribution |
| 445-10G-72PTP | Length 72 in | In distribution |
| 445-10G-48TP | Length 48 in | In distribution |
| 293-2-24TP | Length 24 in | In distribution |
| 445-10S-72TP | Length 72 in | In distribution |
| 263-9P-24RTP | Length 24 in | In distribution |
| 445-10S-60TP | Length 60 in | In distribution |
| 445-10G-72TP | Length 72 in | In distribution |
| 285-32-24B | Length 24 in | In distribution |
| 445-10G-120TP | In distribution | |
| 293-2-48TP | Length 48 in | In distribution |
| 266-9S-36STP | Length 36 in | In distribution |
| 444-10G-96TP | Length 96 in | In distribution |
| 444-10S-120TP | Length 120 in | In distribution |
| 444-10G-60TP | Length 60 in | In distribution |
| 445-10G-96PTP | Length 96 in | In distribution |
| 265-9G-24BTP | Length 24 in | In distribution |
| 444-10G-120TP | Length 120 in | In distribution |
| 293-2SL-48TP | Length 48 in | In distribution |
| 445-10G-48PTP | Length 48 in | In distribution |
| 266-9S-24TP | Length 24 in | In distribution |
| 444-10S-60TP | Length 60 in | In distribution |
| 445-10S-96TP | Length 96 in | In distribution |
| 285-32-48TP | Length 48 in | In distribution |
| 444-10G-72TP | Length 72 in | In distribution |
| 264-9P-24TP | Length 24 in | In distribution |
| 295-2-36STP | Length 36 in | In distribution |
| 444-10S-48TP | Length 48 in | In distribution |
| 445-10G-60TP | Length 60 in | In distribution |
| 445-10S-48TP | Length 48 in | In distribution |
| 266-9G-36STP | Length 36 in | In distribution |
| 444-10S-72TP | Length 72 in | In distribution |
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 |
| Espire Elbow Pro | College Park Industries | 67 |
Showing 12 of 1,006. All products under Electrode, Cutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K953356 | 1996-01-22 |
| K953361 | 1996-01-22 |
| K953354 | 1996-01-22 |
| K952690 | 1995-12-06 |
| K952908 | 1995-12-06 |
| K953220 | 1995-10-06 |
| K953219 | 1995-10-06 |
| K925706 | 1993-02-10 |
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.