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510(k) K213519

Rune Labs Tremor Transducer System by Rune Labs, Inc. — Product Code GYD

K213519 is an FDA 510(k) premarket notification submitted by Rune Labs, Inc. for the device "Rune Labs Tremor Transducer System". The FDA issued a decision of Substantially Equivalent on June 10, 2022. 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
June 10, 2022
Date Received
November 3, 2021
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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  • 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