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510(k) K250153

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

K250153 is an FDA 510(k) premarket notification submitted by Neuhealth Digital , Ltd. for the device "Neu Platform". The FDA issued a decision of Substantially Equivalent on April 25, 2025. The device falls under product code GYD (Transducer, Tremor), a Class II device regulated under 21 CFR 882.1950.

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

Other clearances for product code GYD

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  • K221772 — NeuroRPM (March 17, 2023)
  • K220820 — Parky App (November 17, 2022)
  • K213519 — Rune Labs Tremor Transducer System (June 10, 2022)
  • K211887 — Personal Kinetigraph (PKG) System Gen 2 Plus (March 11, 2022)
  • 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)

FDA data resources