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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
510(k) Number K220738
Device Name Motive Knee Wrap
Applicant
Cymedica Orthopedics, Inc.
2120 E. 6th St.
Tempe,  AZ  85281
Applicant Contact Kereshmeh Shahriari
Correspondent
Cymedica Orthopedics, Inc.
2120 E. 6th St.
Tempe,  AZ  85281
Correspondent Contact Kereshmeh Shahriari
Regulation Number890.5850
Classification Product Code
IPF  
Date Received03/14/2022
Decision Date 05/12/2022
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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