NeuroRPM

510(k)K221772NeurologyGYD

New Touch Digital Inc. is listed for NeuroRPM (K221772). The FDA list gives March 17, 2023 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is GYD. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221772

Official FDA database record

Date of final decision: March 17, 2023
Company on the FDA list: New Touch Digital Inc.
Lead panel: Neurology
Primary product code: GYD
openFDA device name for the code: Transducer, Tremor
Device class: 2
Regulation number: 882.1950
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary