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U.S. Department of Health and Human Services

Product Classification

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Device device, vibration threshold measurement
Regulation Description Two-point discriminator.
Physical State Enforcement discretion applies to devices that do not provide an interpretation or clinical implication of the measurement, in accordance with the FDA guidance, “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements,” issued on August 14, 2015 (https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm407292.pdf)
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeLLN
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NDNB)
Unclassified Reason Pre-Amendment
Submission Type Enforcement Discretion
Regulation Number 882.1200
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible