waveguard XC-153
by eemagine Medical Imaging Solutions GmbH
waveguard XC-153 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 27 Nov 2020 (UDI-DI B195XC153), 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 | NumberB195XC153 | Date27 Nov 2020 | 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 B195XC153 listed 27 Nov 2020 Listed
Timeline
- Cleared FDA 510(k) K110223
- Listed FDA GUDID B195XC153
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- Withdrawn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
- XC-153
- Primary DI / UDI-DI
- B195XC153
- 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).
- ELECTRODE, CUTANEOUS by Cadwell Laboratories, Inc.
- TRU-PULSE PADS by Ipco Corp.
- NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODE by Medicotest, Inc.
- THERAKNIT GARMENT ELECTRODE by NEUROTRON MEDICAL, INC.
- GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) by GE Healthcare
- ELECTRODE ARRAY CAP by Electrode Arrays
- DTL MICROTOUCH EYE ELECTRODE by Lectromedics, Inc.
- Reusable and Self-Adhesive Electrodes by Shaoxing Dongzhi Electrical Technology Co., Ltd.
- ADHESIVE ELECTRODES by Reno Medical, Ltd.
- EMPI REUSEABLE PIN-STYLE TENS ELECTRODE by Empi
Other devices from eemagine Medical Imaging Solutions GmbH
See all devices from eemagine Medical Imaging Solutions GmbH →