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#
- 3004695199
- 3010813366
- 3007731000
- 3014027738
- 3044772099
- 3011077581
- 3001373226
- 1420295
- 3007710601
- 9616494
- 1450057
- 3014579161
- 3008716327
- 3013298431
- 3018940143
- 3006125362
- 8030229
- 3033509895
- 1320894
- 2132556
- 3012316249
- 2113281
- 3002923871
- 1223925
- 1067162
- 3011534533
- 3011766844
- 1055808
- 3004753827
- 3009555600
- 2221819
- 3010402752
- 3016674095
- 3006551156
- 3012321270
- 3017970307
- 2135339
- 3038195193
- 3009492424
- 3003851073
- 9610691
- 3006697681
- 3014659326
- 3010632563
- 3007502541
- 3006258094
- 3007689716
- 8044004
- 9681377
- 3007048259
- 3020018
- 3017448360
- 1045254
- 2013558
- 3046649655
- 3012840029
- 8022257
- 3007603826
- 1526534
- 1056553
- 9613619
- 3043226252
- 3017697481
- 3021602003
- 2939821
- 1721293
- 3005663471
- 3015060202
- 3015531976
- 3008892509
- 2245302
- 3005511941
- 3011267903
- 3010805941
- 3008507279
- 3022631685
- 3030151584
- 3007748793
- 3014692331
Source Documents#
Other 510(k) Records For Product Code GXY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262664 | Rongjian Self-adhesive Electrode | Bozhou Rongjian Medical Appliance Co., Ltd. | 2026-10-20 |
| K262654 | Dexus Prosthetic System (MSL2, MSR2) | Zhejiang Qiangnao Technology Co.,Ltd | 2026-08-27 |
| 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 |
Legacy Summary#
summary
FDA Review#
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