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510(k) K063872

KINESIA by Cleveland Medical Devices, Inc. — Product Code GYD

K063872 is an FDA 510(k) premarket notification submitted by Cleveland Medical Devices, Inc. for the device "KINESIA". The FDA issued a decision of Substantially Equivalent on April 6, 2007. The device falls under product code GYD (Transducer, Tremor), a Class II device regulated under 21 CFR 882.1950. Cleveland Medical Devices, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2007
Date Received
December 29, 2006
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

Other clearances by Cleveland Medical Devices, Inc.

  • K042039 — FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 (November 17, 2004)
  • K013863 — CRYSTAL MONITOR MODEL 16 (February 19, 2002)
  • K001110 — CRYSTAL-EEG MODEL 15 (July 5, 2000)
  • K970672 — CRYSTAL-EEG MODEL 10 (MODEL 10) (May 22, 1997)
  • K964690 — LIBERTY VALVE (March 21, 1997)
  • K962591 — FOOT WEIGHT ALARM (December 4, 1996)
  • K954670 — PRESSORE MONITOR (October 30, 1995)

Other clearances for product code GYD

  • K253055 — Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) (June 17, 2026)
  • K250153 — Neu Platform (April 25, 2025)
  • 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)
  • K010270 — TREMOROMETER (July 25, 2001)
  • K011429 — MODEL 100 ACTIVITY MONITOR (July 13, 2001)

FDA data resources