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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Water Circulating
510(k) Number K213097
Device Name Armory Motion
Applicant
Pain Management Technologies, Inc.
1760 Wadsworth Rd.
Akron,  OH  44320
Applicant Contact Joshua A. Lefkovitz
Correspondent
Pain Management Technologies, Inc.
1760 Wadsworth Rd.
Akron,  OH  44320
Correspondent Contact Joshua A. Lefkovitz
Regulation Number890.5720
Classification Product Code
ILO  
Date Received09/24/2021
Decision Date 06/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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