510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253055Substantially Equivalent

Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)

Nordic Kinetics AB, Lund, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253055 is the FDA 510(k) clearance record for Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”), a class II device, cleared for Nordic Kinetics AB on under FDA product code GYD (Transducer, Tremor). FDA records list one 510(k) clearance for Nordic Kinetics AB. As of , FDA records show no recalls naming K253055.

Clearance record

Decision date
Received
(268 days to decision)
Product code
GYD Transducer, Tremor
Regulation
21 CFR 882.1950
Device class
Class II
Review panel
Neurology
Applicant
Nordic Kinetics AB Skolgatan 3b, Lund, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GYD

Trailing 12 months
3 clearances under product code GYD in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GYD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20262
September 20260
October 20260