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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning
510(k) Number K253478
Device Name Motive™ Muscle Stimulator for Lower Back (OT01-1003)
Applicant
Motive Health, Inc.
2120 E. 6th St.
Suite 8
Tempe,  AZ  85288
Applicant Contact Pete Kilpatrick
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number890.5850
Classification Product Code
NGX  
Date Received10/14/2025
Decision Date 11/06/2025
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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