Rhythmlink®
24 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle and 4 electrodes, 15x20mm recording sticky pad surface electrode with touch proof connector and 1 template,…
24 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle and 4 electrodes, 15x20mm recording sticky pad surface electrode with touch proof connector and 1 template, color-coded 10/20 BraiNet
47manufacturers in China registered for this device type
455catalogue numbers in this listing
6510(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 | Rhythmlink International, LLC, United States |
|---|---|
| FDA product code | GXY |
| Device type | Electrode, Cutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1320 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-17 |
| Record revised | 2023-12-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 10 to 40 °C |
| Packaging | Product box of 3, product box of 20, product box of 4, product box of 40, product box of 2, pack of 3 |
| Distribution end date | 2025-08-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DECUS10026 | 4 | In distribution | |
| MRQWSD308050815 | In distribution | ||
| MRQD32915 | In distribution | ||
| MRQS2070615 | In distribution | ||
| DC31151020 | 31 | In distribution | |
| MRQDW10630 | In distribution | ||
| RLSPGSP120 | In distribution | ||
| RLITD2910 | In distribution | ||
| MRQD32615 | In distribution | ||
| DC24155 | 24 | In distribution | |
| DC241510202 | 24 | In distribution | |
| WEBB2610 | 26 | In distribution | |
| MRQD308081015 | In distribution | ||
| MRQD20909102 | In distribution | ||
| PSTCUS25026 | 2 | In distribution | |
| MRQD309070915 | In distribution | ||
| MRQD22015 | In distribution | ||
| MRDC210 | 12 | In distribution | |
| RLSP518 | In distribution | ||
| DC2815 | 28 | In distribution | |
| HGELS-B | In distribution | ||
| DC2910 | 29 | In distribution | |
| DC110 | 10 | In distribution | |
| MRQD3271525 | In distribution | ||
| SC2515T | 25 | In distribution | |
| DC2515201020 | 25 | In distribution | |
| MRQD3081008152 | In distribution | ||
| MRDC2715 | In distribution | ||
| MRW3015 | 30 | In distribution | |
| DC11512 | 12 | In distribution | |
| MRQD40706070715 | In distribution | ||
| MRQD2070615 | In distribution | ||
| RLSP492 | 3 | In distribution | |
| MRQD310100615 | In distribution | ||
| MRQD10810 | In distribution | ||
| DC11526T | 26 | In distribution | |
| MRDC2710 | 27 | In distribution | |
| MRSPRS8015 | 4 | In distribution | |
| MRSPSL8015 | 4 | In distribution | |
| MRQD307080815 | In distribution | ||
| MRQD309080915 | In distribution | ||
| MRC210 | 12 | In distribution | |
| NCVR40L | 2 | In distribution | |
| MRSPRL4015 | 2 | In distribution | |
| MRQD308070815 | In distribution | ||
| RLSP536 | 3 | In distribution | |
| DC22715 | 27 | In distribution | |
| SC3015 | 30 | In distribution | |
| STCUS15026 | 4 | In distribution | |
| MRQD324102 | In distribution | ||
| MRQS309090515 | In distribution | ||
| PSTCUL25026 | 2 | In distribution | |
| STDTS | In distribution | ||
| DC2615 | 26 | In distribution | |
| SWEBB1215 | 12 | In distribution | |
| MRW310 | 12 | In distribution | |
| MRQD308100815 | In distribution | ||
| NCVG40L-2.0 | In distribution | ||
| DC2510 | 25 | In distribution | |
| MRW210 | 12 | In distribution | |
| DC291520 | 29 | In distribution | |
| MRSPSS8025 | 4 | In distribution | |
| MRQD329153 | In distribution | ||
| DC2710 | 27 | In distribution | |
| MRQW32410 | In distribution | ||
| PSGDSP1530 | In distribution | ||
| RLSP528 | 6 | In distribution | |
| MRQD43315 | In distribution | ||
| MRQD323154 | In distribution | ||
| MRQW3241520 | In distribution | ||
| RLSPGSP120-AU | In distribution | ||
| DC1715 | 17 | In distribution | |
| DC25101020 | 25 | In distribution | |
| DAGD252600 | 10 | In distribution | |
| WEBB2615 | 26 | In distribution | |
| MRSPSL8025 | 4 | In distribution | |
| MRQD42615 | In distribution | ||
| MRQDC310101015 | In distribution | ||
| MRQWD304040515 | In distribution | ||
| MRW2415 | 24 | In distribution | |
| NCV115 | 3 | In distribution | |
| MRW315 | 12 | In distribution | |
| CTDC2615 | 26 | In distribution | |
| WEBB152900 | 10 | In distribution | |
| MRQD44015 | In distribution | ||
| PDECUS15026 | 2 | In distribution | |
| MRDC3015 | 30 | In distribution | |
| STDTM | In distribution | ||
| STCUS30026 | 4 | In distribution | |
| STCUS25026 | 4 | In distribution | |
| PDECUS25026 | 2 | In distribution | |
| NCVKIT15 | 6 | In distribution | |
| DC22515 | 25 | In distribution | |
| DC2715 | 27 | In distribution | |
| MRQD309090515 | In distribution | ||
| PDECUL15026 | 2 | In distribution | |
| DCDECUL22251530 | In distribution | ||
| MRQDW308080915 | In distribution | ||
| DCSC211530 | 21 | In distribution | |
| MRDC2515 | 25 | In distribution | |
| DCW2615 | 26 | In distribution | |
| MRQD309060910 | In distribution | ||
| 293-2-24TP | In distribution | ||
| WEBB2315 | 23 | In distribution | |
| MRQW32415 | In distribution | ||
| MRSPSTMRECG1525 | In distribution | ||
| DAGDWEBB2615 | In distribution | ||
| MRQW308080915 | In distribution | ||
| MRC515 | 12 | In distribution | |
| WEBB1420 | 14 | In distribution | |
| MRQD322615 | In distribution | ||
| MRQD40606060715 | In distribution | ||
| CTDC26151020 | 26 | In distribution | |
| CTC115 | 12 | In distribution | |
| RLSP482 | 2 | In distribution | |
| DC27151020 | 27 | In distribution | |
| NCVT100 | 10 | In distribution | |
| DC115 | 10 | In distribution | |
| NCVT80L | 2 | In distribution | |
| MRQD33015 | In distribution | ||
| MRW615 | 6 | In distribution | |
| MRSPRS4025 | In distribution | ||
| MRQD310100315 | In distribution | ||
| MRQD310100715 | In distribution | ||
| CTDC115 | 12 | In distribution | |
| MRQD310101010 | In distribution | ||
| STMRECG261525 | In distribution | ||
| RLIT131-1.0 | In distribution | ||
| MRQD33020 | In distribution | ||
| DCW27152 | 27 | In distribution | |
| DC28152 | 28 | In distribution | |
| DC115T | 10 | In distribution | |
| MRWDC1710 | In distribution | ||
| DC125 | 10 | In distribution | |
| DAGD152600 | 10 | In distribution | |
| DC2515 | 25 | In distribution | |
| MRQS307070815 | In distribution | ||
| MRQD42610 | In distribution | ||
| DC33151020 | 33 | In distribution | |
| MRQD323153 | In distribution | ||
| DAGD302600 | 10 | In distribution | |
| MRQS32815 | In distribution | ||
| MRQD32515 | In distribution | ||
| DC1520 | 15 | In distribution | |
| DC24151020 | 24 | In distribution | |
| SCDECUS261015 | In distribution | ||
| MRDC2615 | 26 | In distribution | |
| DC24153 | 24 | In distribution | |
| STDTL | In distribution | ||
| SC2325 | 23 | In distribution | |
| DCDECUG261525 | In distribution | ||
| MRW415 | 12 | In distribution | |
| WEBB2715 | 27 | In distribution | |
| DC2310 | 23 | In distribution | |
| DC27152 | In distribution | ||
| MRQS33215 | In distribution | ||
| MRQDW310100515 | In distribution | ||
| MRQD40606060515 | In distribution | ||
| DECUL15026 | 4 | In distribution | |
| MRW225 | 12 | In distribution | |
| WEBB2310C | 23 | In distribution | |
| CTDC2715 | 27 | In distribution | |
| MRQS32410 | In distribution | ||
| DC1615 | 16 | In distribution | |
| MRSPRS8025 | 4 | In distribution | |
| NCVD80L | 4 | In distribution | |
| MRQS232415 | In distribution | ||
| DC2520T | 25 | In distribution | |
| CTDC4415 | 2 | In distribution | |
| DC25151020 | 25 | In distribution | |
| DC2215 | 22 | In distribution | |
| MRDC315 | 12 | In distribution | |
| DC2415 | 24 | In distribution | |
| MRQD40707060515 | In distribution | ||
| MRDC515 | 12 | In distribution | |
| MRQD2060715 | In distribution | ||
| MRQWSD308080515 | In distribution | ||
| MRQD310041015 | In distribution | ||
| STCUL15026 | 4 | In distribution | |
| MRQD32410 | In distribution | ||
| DC2520 | 25 | In distribution | |
| CTDC2215 | 22 | In distribution | |
| DECUG15026 | In distribution | ||
| SC2315T | 23 | In distribution | |
| MRQD21915 | In distribution | ||
| DCDECUL232530 | In distribution | ||
| SCDECUL2225 | In distribution | ||
| CTDC3515 | 35 | In distribution | |
| MRDC2915 | 29 | In distribution | |
| MRC510 | 12 | In distribution | |
| 293-2SL-48TP | In distribution | ||
| MRQD4241525 | In distribution | ||
| MRQD3090409015 | In distribution | ||
| RLSP516 | In distribution | ||
| DECUS25026 | 4 | In distribution | |
| MRQD307070710 | In distribution | ||
| MRC410 | 12 | In distribution | |
| RLSP537 | 4 | In distribution | |
| MRDC225 | 12 | In distribution | |
| MRQD310100515 | In distribution | ||
| SC11026 | 26 | In distribution | |
| MRC3015 | 30 | In distribution | |
| MRDC2415 | 24 | In distribution | |
| MRQD32315 | In distribution | ||
| DAGDWEBB1215 | In distribution | ||
| DC2620 | 26 | In distribution | |
| SC2520 | 25 | In distribution | |
| DC11526 | 26 | In distribution | |
| DC2315 | 23 | In distribution | |
| MRQD324152 | In distribution | ||
| DCPSG1520 | 15 | In distribution | |
| MRQD40710071015 | In distribution | ||
| MRSPG4015 | In distribution | ||
| MRQW42615 | In distribution | ||
| WEBB252900 | 10 | In distribution | |
| MRQD42515 | In distribution | ||
| NCVR100 | 10 | In distribution | |
| RLSP210 | In distribution | ||
| SPDC1810 | 18 | In distribution | |
| PSTCUL15026 | 2 | In distribution | |
| DCDECUL291525 | In distribution | ||
| DC2915 | 29 | In distribution | |
| MRQD310061015 | In distribution | ||
| MRSPRL8025 | 4 | In distribution | |
| SPDC0615 | 6 | In distribution | |
| SC2315 | 23 | In distribution | |
| MRC310 | 12 | In distribution | |
| CTDC3020 | 30 | In distribution | |
| DC241520 | 24 | In distribution | |
| CTSW2715 | In distribution | ||
| NCVG50 | 2 | In distribution | |
| WEBB2710 | 27 | In distribution | |
| CTDC2825 | 28 | In distribution | |
| MRSPSS8015 | 4 | In distribution | |
| MRQD20707152 | In distribution | ||
| SCPSG1520SP2530 | In distribution | ||
| WEBB22315 | 23 | In distribution | |
| MRQD428152 | In distribution | ||
| DCDECUL2815 | In distribution | ||
| MRQD20706152 | In distribution | ||
| RLSP519-02 | 2 | In distribution | |
| DC2615201020 | 26 | In distribution | |
| DCDECUL271015 | In distribution | ||
| MRDC325 | 12 | In distribution | |
| PDECUL25026 | 2 | In distribution | |
| MRQW2090815 | In distribution | ||
| DAGD102600 | 10 | In distribution | |
| MRQD3100610152 | In distribution | ||
| MRQW32610 | In distribution | ||
| ICUTSM | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Natus | Natus Neurology Incorporated | 66 |
Showing 12 of 1,006. All products under Electrode, Cutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203079 | 2021-02-09 |
| K191225 | 2019-08-05 |
| K172503 | 2017-12-01 |
| K130287 | 2013-05-30 |
| K061148 | 2006-05-10 |
| K052188 | 2005-08-23 |
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.