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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Tremor
510(k) Number K253055
Device Name Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)
Applicant
Nordic Kinetics AB
Skolgatan 3b
Lund,  SE 223 61
Applicant Contact Jakob V. E. Gerstl
Correspondent
Nordic Kinetics AB
Skolgatan 3b
Lund,  SE 223 61
Correspondent Contact Jakob V. E. Gerstl
Regulation Number882.1950
Classification Product Code
GYD  
Subsequent Product Code
NXQ  
Date Received09/22/2025
Decision Date 06/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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