510(k) K262654
- Device
- Dexus Prosthetic System (MSL2, MSR2)
- Applicant
- Zhejiang Qiangnao Technology Co.,Ltd
- 510(k) number
- K262654
- Product code
- GXY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-27
- Date received
- 2026-07-30
- Regulation
- 882.1320
- Classification name
- Electrode, Cutaneous
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Guifang Dai
- Address
- Rm. 201-5, Bldg. 1, #1818-2, Wenyi W. Rd., Yuhang St., Yuhan Hangzhou CN 310000 310000
FDA Registration Numbers#
- 3009656988
- 1223925
- 3015060202
- 3013426279
- 2936999
- 3013671918
- 3010852191
- 3031464228
- 3013557562
- 3009156722
- 3013378804
- 3012321270
- 3019822804
- 1060680
- 3003895865
- 3006551156
- 3008716327
- 1056553
- 3012494290
- 3008197884
- 3045321552
- 3030597665
- 3007502541
- 2221819
- 9616494
- 3016674095
- 1055808
- 3003072803
- 3017953405
- 3005190268
- 3010813366
- 3010605876
- 3013957847
- 9610691
- 9710602
- 9710580
- 2013558
- 3003749270
- 9612389
- 3015531976
- 2939821
- 3018940143
- 3017887928
- 9681377
- 3005511941
- 3014659326
- 3016852448
- 3013671142
- 3004426795
- 1063285
- 9612330
- 3004839404
- 3014649088
- 3021826057
- 3017450375
- 3005569927
- 3011534533
- 3002923871
- 3013298431
- 3023613474
- 1043214
- 1423537
- 1721293
- 3010515191
- 8030245
- 3038195193
- 3022954003
- 3010611950
- 3020018
- 3043013796
- 8010720
- 3006258094
- 3014692331
- 1626185
- 3011466827
- 3005170249
- 3007836437
- 3012680643
- 3019878714
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 |