DeviceClearance

Product code NTU— Neurology

CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS)

Classification name
Evoked Potential Stimulator, Thermal
Device class
Class 2
Regulation
21 CFR 882.1870
Advisory panel
Neurology
Total cleared
3
First cleared
Most recent

FDA classification definition

“Intended to evaluate the functionality of human pain reception and transmission of sensory pathways”

— U.S. Food and Drug Administration, device classification record for product code NTU under 21 CFR 882.1870, via openFDA

Market context for product code NTU

FDA has cleared 3 devices under product code NTU between 2005 and 2006, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NTU

Recent clearances under product code NTU

Data sourced from openFDA. This site is unofficial and independent of the FDA.