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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K260586
Device Name Nimbl™ Pneumatic Compression System
Applicant
Tactile Medical
3701 Wayzata Blvd.
Suite 300
Minneapolis,  MN  55416
Applicant Contact Sunday Hoy
Correspondent
DuVal & Associates, P.A.
Medical Arts Bldg., 825 Nicollet Mall
Suite 1820
Minneapolis,  MN  55402
Correspondent Contact Mark Spreeman
Regulation Number870.5800
Classification Product Code
JOW  
Date Received02/20/2026
Decision Date 10/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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