510(k) K911366
- Device
- PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE
- Applicant
- MEDICAL DESIGN & MANUFACTURING CORP.
- 510(k) number
- K911366
- Product code
- GXY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-09-27
- Date received
- 1991-03-28
- Regulation
- 882.1320
- Classification name
- Electrode, Cutaneous
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- H SOUTHWORTH
- Address
- 929 Eastwind Dr. Westerville OH US 43081 43081
FDA Registration Numbers#
- 3008048783
- 8030229
- 3006153348
- 3023164
- 3003851073
- 3005713796
- 3022954003
- 1223925
- 3009156722
- 3008729899
- 3015429360
- 3008806011
- 3021826057
- 1055808
- 9617486
- 3008525454
- 3009171251
- 1423662
- 3012316249
- 3012840029
- 2031094
- 3017619536
- 3005463575
- 3004786509
- 3030978471
- 3010515191
- 3009499478
- 3008273892
- 3009492424
- 2245302
- 8022890
- 1067162
- 3011353843
- 3016674095
- 3012176966
- 3031464228
- 1626185
- 2221819
- 3003573572
- 3027718340
- 3033509895
- 3003749270
- 2936999
- 8030245
- 1317188
- 3010813366
- 3022631685
- 9612243
- 3019865183
- 3027329006
- 9616086
- 1052723
- 3015614098
- 1450057
- 3018070844
- 3017264244
- 2939821
- 3006551156
- 3018094310
- 1056553
- 3010078417
- 3030597665
- 3016852448
- 1930027
- 2000004234
- 3013298431
- 3010611950
- 3013426279
- 9710580
- 3017448360
- 3005190268
- 3009555600
- 3042268484
- 8044004
- 3008716327
- 3003446042
- 3015060202
- 3008312728
- 1047843
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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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