510(k) K092793
- Device
- MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411
- Applicant
- BIO-MEDICAL RESEARCH, LTD.
- 510(k) number
- K092793
- Product code
- GXY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-12-07
- Date received
- 2009-09-11
- 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
- ANNE-MARIE KEENAN
- Address
- Parkmore Business Park W. Galway IE
FDA Registration Numbers#
- 8010720
- 3006258094
- 8022257
- 3004920696
- 3014692331
- 3007028037
- 3026753375
- 1721293
- 3005955744
- 8022189
- 3012321270
- 3005581270
- 3004558433
- 3001373226
- 3014659326
- 3042268484
- 3022631685
- 3003851073
- 9710376
- 3006125362
- 3011534533
- 9616086
- 2013558
- 1056553
- 3012316249
- 3010515191
- 3013426279
- 3014314933
- 3027718340
- 8030229
- 3023707151
- 3013671142
- 3017887928
- 3020018
- 3043226252
- 2031094
- 3010611950
- 3006626283
- 3007731000
- 3015429360
- 3030978471
- 3011310592
- 3009492424
- 3004040397
- 3007689716
- 3005569927
- 3021192567
- 3005713796
- 3006636961
- 8022890
- 1043214
- 3009156722
- 3015060202
- 3025186177
- 3027256461
- 8030245
- 3007836437
- 3008507279
- 8044004
- 3017210488
- 3013957847
- 3015531976
- 3011766844
- 3021826057
- 3013500228
- 3014579161
- 3010417025
- 3017448360
- 8022077
- 3006697681
- 9612389
- 3024892936
- 3007603826
- 9613619
- 3004786509
- 3004426795
- 3003573572
- 3008197884
- 3006850006
Source Documents#
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#
summary
FDA Review#
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