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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 K241256
Device Name JetBoots PRO Plus
Applicant
Therabody, Inc.
1640 S Sepulveda Blvd.
Suite 300
Los Angeles,  CA  90025
Applicant Contact CJ Frederick, III
Correspondent
Gpw Enterprises, LLC
47 Gatehouse Rd.
Bedminster,  NJ  07921
Correspondent Contact Gina Walljasper
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Codes
ILY   IRO  
Date Received05/06/2024
Decision Date 08/30/2024
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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