510(k) K050469
- Device
- EZ-STIK ELECTRODES
- Applicant
- NAIMCO, INC.
- 510(k) number
- K050469
- Product code
- GXY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-05-13
- Date received
- 2005-02-23
- 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
- ROBERT L MCCLURE
- Address
- 4120 S. Creek Rd. Chattanooga TN US 37406 37406
FDA Registration Numbers#
- 9710051
- 1626185
- 9613619
- 9612330
- 9710602
- 3010417025
- 3008197884
- 3009492424
- 3012725363
- 3027532607
- 1047843
- 3030597665
- 3005581220
- 8022189
- 3017887928
- 3013298431
- 3025186177
- 9610691
- 3009656988
- 3008716327
- 3009171251
- 3010611950
- 9710580
- 8020045
- 8030245
- 3003895865
- 3008806011
- 3023613474
- 3011267903
- 3008729899
- 3010632563
- 3004903538
- 3015531976
- 3004426795
- 3017448360
- 3015614098
- 3016852448
- 1930027
- 3005581270
- 3014692331
- 9612243
- 2031094
- 1650946
- 3012176966
- 3043013796
- 9616086
- 3011191255
- 2113281
- 3008507279
- 1055808
- 3006315274
- 2132556
- 9710582
- 3014659326
- 9616494
- 2245302
- 3001373226
- 1043214
- 3004040397
- 3017450375
- 3017697481
- 3011307234
- 1052723
- 3023707151
- 3033509895
- 3045321552
- 3004146401
- 3016674095
- 3004558433
- 3006697681
- 1644243
- 3010805941
- 3004920696
- 3020494684
- 3013671142
- 3014649088
- 3010402752
- 3028172072
- 3005569927
Source Documents#
Other 510(k) Records For Product Code GXY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US) | Ambu A/S | 2026-07-14 |
| 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 |
Legacy Summary#
summary
FDA Review#
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