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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 K220217
Device Name Normatec 3
Applicant
NormaTec Industries, LP
480 Pleasant St., Suite A200
Watertown,  MA  02472
Applicant Contact Steve Henderson
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number890.5650
Classification Product Code
IRP  
Date Received01/26/2022
Decision Date 02/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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