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510(k) K250153

Neu Platform by Neuhealth Digital , Ltd. — Product Code GYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2025
Date Received
January 21, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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)
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