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510(k) K221772

NeuroRPM by New Touch Digital, Inc. — Product Code GYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2023
Date Received
June 21, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Tremor
Device Class
Class II
Regulation Number
882.1950
Review Panel
NE
Submission Type

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  • K161717 — Personal Kinetigraph (PKG) System (September 20, 2016)
  • K140086 — PERSONAL KINETIGRAPH (PKG) SYSTEM (August 22, 2014)
  • K063872 — KINESIA (April 6, 2007)
  • K010270 — TREMOROMETER (July 25, 2001)
  • K011429 — MODEL 100 ACTIVITY MONITOR (July 13, 2001)
  • K971318 — MM-1 MOVEMENT MONITOR (July 28, 1997)