waveguard CA-520
by eemagine Medical Imaging Solutions GmbH
waveguard CA-520 is an electroencephalographic electrode cap (FDA Class II; FDA product code GXY, Electrode, cutaneous) made by eemagine Medical Imaging Solutions GmbH, cleared under FDA 510(k) K110223 on 29 Jun 2011 and listed in FDA GUDID since 16 Dec 2025 (UDI-DI B195CA520), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB195CA520 | Date16 Dec 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110223 | Date29 Jun 2011 | StatusActive |
Official records
- FDA 510(k) database K110223
Across registries
- FDA 510(k) K110223 decided 29 Jun 2011 Active
- FDA GUDID UDI-DI B195CA520 listed 16 Dec 2025 Listed
Timeline
- Cleared FDA 510(k) K110223
- Listed FDA GUDID B195CA520
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- waveguard
- Generic name
- Electroencephalographic electrode cap, reusable
- Model / reference
- CA-520
- Primary DI / UDI-DI
- B195CA520
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Electroencephalographic electrode cap, reusable
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GXY (Electrode, cutaneous).
- REFERENCE & MONITORING ELECTRODE by Precision Cap Systems
- Wandy Self-Adhesive Neurostimulation Electrode by Wandy Rubber Industrial Co., Ltd
- VERI/TRODES by Verite Scientific, Inc.
- Adhesive Electrodes by Shenzhen Quality Medical Technology Co., Ltd
- Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes by BIO PROTECH INC.
- Suction Socket Electrode 13E202=50 by Otto Bock Healthcare Products GmbH
- SENTRY FLEXIBLE TENS by Sentry Medical Products, Inc.
- SMD ELECTRODES by Scientific Medical Devices, Inc.
- DISPOSABLE PRE-GELLED SURFACE ELECTRODE by ROCHESTER ELECTRO-MEDICAL, INC.
- JIAJIAN SELF-ADHESIVE ELECTRODE by Wuxi Jiajian Medical Instrument Co., Ltd.
Other devices from eemagine Medical Imaging Solutions GmbH
See all devices from eemagine Medical Imaging Solutions GmbH →