510(k) K120516
- Device
- LONG LIFE PADTM
- Applicant
- OMRON HEALTHCARE, INC.
- 510(k) number
- K120516
- Product code
- GXY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-05-17
- Date received
- 2012-02-21
- 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
- PAUL DRYDEN
- Address
- 24301 Woodsage Dr. Bonita Springs FL US 34134 34134
FDA Registration Numbers#
- 3009555600
- 2936999
- 3005698910
- 8020045
- 3017264244
- 1650946
- 1526534
- 3030151584
- 3008255748
- 3008312728
- 3005581270
- 3033509895
- 3023164
- 1522166
- 3011506263
- 3013500228
- 3018094310
- 3008048783
- 3027718340
- 3011267903
- 3008202779
- 8022890
- 3038195193
- 1060680
- 3004415095
- 1055808
- 3015614098
- 1644243
- 3007748793
- 3017970307
- 3011412151
- 3010417025
- 8022077
- 3021192567
- 3027256461
- 1052723
- 1420295
- 9616494
- 3005713796
- 3009351773
- 3009499478
- 3008525454
- 8044004
- 9710582
- 3017697481
- 3015531976
- 2113281
- 3014027738
- 3004146401
- 3006636961
- 8022257
- 3015429360
- 3004753827
- 9710602
- 1045254
- 3013596024
- 3026753375
- 3013671918
- 3004786509
- 3022631685
- 3017448360
- 9613619
- 3005511941
- 3008892509
- 2031094
- 9612243
- 3023237645
- 3019865183
- 3007028037
- 3009831876
- 3013957847
- 3007731000
- 3011307234
- 3013757456
- 3029973920
- 9610105
- 3004558433
- 3004695199
- 3007689716
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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