FDA warns Non-Invasive Monitoring Systems over device marketing

03/28/2011 | MassDevice.com (Boston)

Non-Invasive Monitoring Systems has received an FDA warning letter saying the company is promoting its Exer-Rest whole body periodic acceleration device for off-label uses. The company counters that its product has status as a Class I exempt device, claiming that 510(k) clearance studies and medical device premarket approval aren't necessary.

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MassDevice.com (Boston)

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