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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Extracellular Fluid, Lymphedema, Extremity
510(k) Number K261628
Device Name LymphaTech Mobile 3D Measuring Tool
Applicant
Lymphatech, Inc.
101 Nerem St. NW
Suite 1000
Atlanta,  GA  30313
Applicant Contact Mike Weiler
Correspondent
Powers Regulatory Consulting
2451 Cumberland Pkwy. SE
Suite 3740
Atlanta,  GA  30339
Correspondent Contact Grace Powers
Regulation Number870.2770
Classification Product Code
OBH  
Subsequent Product Code
SFG  
Date Received05/15/2026
Decision Date 10/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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