510(k) K092546
- Device
- GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM
- Applicant
- GMDASZ MANUFACTURING CO., LTD
- 510(k) number
- K092546
- Product code
- GXY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-12-18
- Date received
- 2009-08-19
- Regulation
- 882.1320
- Classification name
- Electrode, Cutaneous
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLIE MACK
- Address
- 77325 Joyce Way Echo OR US 97826 97826
FDA Registration Numbers#
- 1522166
- 2031094
- 1067162
- 3014314933
- 3017887928
- 8044004
- 3008507279
- 2013558
- 3003446042
- 1060680
- 3005170249
- 3007689716
- 3013500228
- 3014027738
- 2025066
- 3029973920
- 3018070844
- 3008657519
- 3008202779
- 3008048783
- 3009555600
- 3003749270
- 3021192567
- 3003851073
- 3010402752
- 3002893037
- 3030597665
- 3001373226
- 3016674095
- 3008806011
- 3011077581
- 3007048259
- 9610105
- 3005569927
- 3023164
- 3017953405
- 3033509895
- 3025186177
- 3023613474
- 3007710601
- 3014647250
- 3038195193
- 1650946
- 3006153348
- 1055808
- 3019388613
- 3020494684
- 3003895865
- 1056553
- 2025694
- 3020018
- 3007603826
- 2000004234
- 2135339
- 3007748793
- 3002923871
- 3010078417
- 3006850006
- 2245302
- 3013378804
- 9617486
- 3008273892
- 9612330
- 3030151584
- 1930027
- 3003971136
- 9681860
- 3013426279
- 9612389
- 3012316249
- 3011267903
- 2936999
- 2024024
- 3012725363
- 3014659326
- 3008008477
- 3028172072
- 3011307234
- 8030245
Source Documents#
Other 510(k) Records For Product Code GXY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | 2026-05-08 |
| K254183 | MR Conditional Cup Electrodes | Technomed Europe | 2026-05-07 |
| K252439 | Tutamen Self Adhesive Electrodes | Dongguan Tutamen Metalwork Co., Ltd. | 2026-05-01 |
| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Otto Bock Healthcare Products GmbH | 2026-04-22 |
| K260363 | Ceribell Brain Monitor Headband | Ceribell, Inc. | 2026-04-03 |
| K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | Bionit Labs Srl | 2026-03-12 |
| K254033 | Ceribell Instant EEG Headset | Ceribell, Inc. | 2026-02-09 |
| K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Ceribell, Inc. | 2025-10-31 |
| K250841 | Electrotherapy Electrodes | Baisheng Medical Co., Ltd. | 2025-08-13 |
| K243788 | IceCap product line | Bioserenity Medical Devices Group | 2025-03-13 |
| K243243 | Delphi MCS Electrode Cap | Quantalx Neuroscience, Ltd. | 2025-02-06 |
| K241512 | Electrode Pad | Shenzhen Deliduo Medical Technology Co.,Ltd | 2025-01-15 |
| K242326 | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | Bionit Labs Srl | 2025-01-02 |
| K241160 | CAIs Sensor (CAIs-001) | Brainu Co., Ltd. | 2024-12-13 |
| K240575 | WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) | Eemagine Medical Imaging Solutions GmbH | 2024-11-25 |
Legacy Summary#
summary
FDA Review#
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