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SX230FW EMG Sensor
BIOMETRICS LIMITED · Model SX230FW · UDI-DI 05060481691468
10
510(k) clearances
59
Adverse events (1 deaths)
4
Recalls
108
Facilities
Description
The SX230FW EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. The EMG Amplifier (SX230FW) uses disposable electrodes and has a variable electrode distance. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 SX230FW EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Plastic connector
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-11 | RONAN MEDICAL LLC | Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended. |
| 2017-07-07 | Ondamed Inc | The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regulations. The firm has |
| 2015-10-01 | Powers Medical Devices, LLC | PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k). |
| 2012-11-15 | EEG Info | EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.