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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K251905
Device Name Normatec Elite Hip
Applicant
NormaTec Industries, LP
480 Pleasant St., Suite A200
Watertown,  MA  02472
Applicant Contact Steve Henderson
Correspondent
ProMedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Matt Dryden
Regulation Number890.5650
Classification Product Code
IRP  
Date Received06/20/2025
Decision Date 09/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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