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Biometrics Ltd Pinchmeter

BIOMETRICS LIMITED · Model P200 · UDI-DI 05060481690034

HCC ISD IKK

510(k) clearances

Adverse events (1 deaths)

Recalls

109

Facilities

Description

The unique electronic pinchmeter has a low profile design that enables the researcher to accurately quantify pinch strength at closer to end range than any other device. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013.

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.