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DataLITE Management + Analysis Software (Version 10)

BIOMETRICS LIMITED · Model 510xx-11 · UDI-DI 05060481690867

HCC IKK KQX

510(k) clearances

Adverse events (1 deaths)

Recalls

108

Facilities

Description

The Biometrics Analysis Software is a comprehensive tool for EMG, Goniometer and associated sensor analysis including real-time data analysis as the data is collected. The Analysis software also contains all of the features of the Management Software: The DataLITE Management Software allows the user to set up the DataLITE communications with the computer, configure the DataLITE sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data Software is available in English, Chinese, and Japanese.

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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Data 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.