GXY · Electrode, Cutaneous · Chrysalis Intelligence

Device class

Class II

Regulation 882.1320

Total clearances

2020-01-21 → 2026-08-27

Last 12 months

Unique sponsors

Classification details

Medical specialty

Neurology

Review panel

Regulation number

882.1320

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Ceribell, Inc.	6	3	2026-04-03
Guangzhou Xinbo Electronic Co., Ltd.	4	0	2023-08-09
Bionit Labs Srl	2	1	2026-03-12
Shenzhen Roundwhale Technology Co. , Ltd.	2	0	2024-01-11
Zhejiang Qiangnao Technology Co.,Ltd	2	1	2026-08-27
Coapt	2	0	2023-01-11
Biowave Corporation	2	1	2026-06-03
Prolira B.V.	1	0	2023-02-02
Cymedica Orthopedics, Inc.	1	0	2023-03-22
Memory MD, Inc.	1	0	2021-03-05
Shenzhen Xingyuanli Technology Co., Ltd.	1	0	2023-03-24
Technomed Europe	1	1	2026-05-07
Shenzhen Changke Connect Electronics Co., Ltd.	1	0	2022-05-06
Otto Bock Healthcare Products GmbH	1	1	2026-04-22
Cadwell Industries, Inc.	1	1	2026-06-26
Electrode Market Co., Ltd.	1	0	2021-07-28
Shenzhen Amydi-Med Electrics Tech Co., Ltd.	1	0	2024-03-19
Rhythmlink International, LLC	1	0	2021-02-09
Gymmax Technology Shenzhen Co., Ltd.	1	0	2024-06-10
Natus Manufacturing Limited	1	0	2024-08-29
Brainu Co., Ltd.	1	0	2024-12-13
Quantalx Neuroscience, Ltd.	1	0	2025-02-06
Green Island International Tcm Group Limited	1	0	2023-12-19
Pamel D.O.O	1	0	2021-11-09
Eemagine Medical Imaging Solutions GmbH	1	0	2024-11-25

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
95812	CPT	—	High	Electroencephalogram (EEG); cutaneous electrodes are standard in routine EEG monitoring
A4556	HCPCS	Electrodes, (e.g., apnea monitor), per pair ✓ CMS-verified description	Medium	Electrode/transducer for use with EEG; HCPCS supply code for electrode materials

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-27	K262654	Zhejiang Qiangnao Technology Co.,Ltd	Dexus Prosthetic System (MSL2, MSR2)
2026-07-14	K260578	Ambu A/S	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)
2026-06-26	K261442	Cadwell Industries, Inc.	Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
2026-06-03	K261522	Biowave Corporation	BioWave BioWraps
2026-05-08	K253237	Elde Medikal Sanayi ve Ticaret Anonim Sirketi	Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
2026-05-07	K254183	Technomed Europe	MR Conditional Cup Electrodes
2026-05-01	K252439	Dongguan Tutamen Metalwork Co., Ltd.	Tutamen Self Adhesive Electrodes
2026-04-22	K253256	Otto Bock Healthcare Products GmbH	myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
2026-04-03	K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband
2026-03-12	K260453	Bionit Labs Srl	Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)
2026-02-09	K254033	Ceribell, Inc.	Ceribell Instant EEG Headset
2025-10-31	K251381	Ceribell, Inc.	Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
2025-08-13	K250841	Baisheng Medical Co., Ltd.	Electrotherapy Electrodes
2025-03-13	K243788	Bioserenity Medical Devices Group	IceCap product line
2025-02-06	K243243	Quantalx Neuroscience, Ltd.	Delphi MCS Electrode Cap
2025-01-15	K241512	Shenzhen Deliduo Medical Technology Co.,Ltd	Electrode Pad
2025-01-02	K242326	Bionit Labs Srl	Wave Electrode (AE02-60); Wave Electrode (AE02-50)
2024-12-13	K241160	Brainu Co., Ltd.	CAIs Sensor (CAIs-001)
2024-11-25	K240575	Eemagine Medical Imaging Solutions GmbH	WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)
2024-08-29	K242346	Natus Manufacturing Limited	Grass® MR Conditional/CT Cup Electrodes
2024-06-10	K240108	Gymmax Technology Shenzhen Co., Ltd.	Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01)
2024-04-15	K240884	Infinite Biomedical Technologies, LLC	Glide (91000-GL-X)
2024-03-19	K240668	Shenzhen Amydi-Med Electrics Tech Co., Ltd.	Amydi-med Disposable Non-invasive EEG electrodes
2024-01-11	K232995	Shenzhen Roundwhale Technology Co. , Ltd.	Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe
2023-12-19	K221199	Green Island International Tcm Group Limited	Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)