CBL.ASX: US FDA Registration and Device Listing for NeuroStrip

US FDA Registration and Device Listing for NeuroStrip

Stock	Control Bionics Ltd (CBL.ASX)
Release Time	4 Aug 2026, 8:26 a.m.
Price Sensitive	Yes

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Control Bionics Achieves FDA Registration for NeuroStrip

Key Points

NeuroStrip registered and listed with US FDA
Registration number is 3006789226, listing number is D605008
Strengthens positioning for advanced applications
Supports broader regulatory strategy
Applications pending in Australia, EU, and UK

Full Summary

Control Bionics Limited (ASX: CBL) announced that its NeuroStrip surface EMG wearable platform has been registered and listed with the United States Food and Drug Administration (FDA) as a medical device. This registration formalizes NeuroStrip's status within the US regulatory framework, with a registration number of 3006789226 and listing number D605008. This milestone reinforces NeuroStrip's credentials as a medical-grade device and supports the company's broader regulatory strategy. Although not necessary for its existing use in sports performance and general rehabilitation, the FDA registration enhances the platform's commercial appeal in advanced clinical rehabilitation, medical research, and human-computer interface applications. Control Bionics has also submitted applications for regulatory approval in Australia, the EU, and the UK.