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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K220698
Device Name Bambino 3, S3 and S3 Swing, U3 and U3 Light, X
Applicant
Panthera AB
Gunnebogatan 26
Stockholm,  SE 16353
Applicant Contact Fredrik Stantz
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Stuart R. Goldman
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/09/2022
Decision Date 02/16/2023
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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