510(k) K173186
- Device
- S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D
- Applicant
- Everyway Medical Instruments Co., Ltd.
- 510(k) number
- K173186
- Product code
- GXY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-02-28
- Date received
- 2017-10-02
- Regulation
- 882.1320
- Classification name
- Electrode, Cutaneous
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Paul Hung
- Address
- 3fl., # 5, Ln. 155, Sec. 3 Beishen Rd. Shenkeng Dist. New Taipei City TW 22203 22203
FDA Registration Numbers#
- 3011353843
- 3012680643
- 3002923871
- 3015429360
- 3005581220
- 9617486
- 3009555600
- 3015060202
- 9616877
- 3013069546
- 8030229
- 3012725363
- 1650946
- 3030151584
- 1626185
- 3014649088
- 3005511941
- 1047843
- 3011905669
- 3013500228
- 3006258094
- 3017210488
- 1317188
- 9612243
- 8030245
- 3011310592
- 9610105
- 3021826057
- 3005663471
- 3017697481
- 3008716327
- 3008255748
- 3004415095
- 3006315274
- 3008729899
- 9710376
- 3005569927
- 3011466827
- 1423537
- 9710582
- 8022257
- 3022631685
- 3007836437
- 3014647250
- 3028172072
- 3008806011
- 3031464228
- 1043214
- 3007710601
- 3027329006
- 3030597665
- 2113281
- 1644243
- 3004695199
- 3014027738
- 1052723
- 3044563261
- 3008048783
- 3005698910
- 3009156722
- 3018094310
- 3007028037
- 3008312728
- 3008008477
- 1930027
- 9710051
- 3014579161
- 8044004
- 3004040397
- 3023164
- 3012316249
- 3030978471
- 3036833452
- 3020018
- 3018940143
- 3008197884
- 3011307234
- 3025186177
- 3005713796
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GXY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | Cadwell Industries, Inc. | 2026-06-26 |
| K261522 | BioWave BioWraps | Biowave Corporation | 2026-06-03 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases