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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 K203552
Device Name Rapid Reboot
Applicant
Rapid Reboot Recovery Products, LLC
1396 W 200 S, Building 2, Unit A
Lindon,  UT  84042
Applicant Contact David Johnson
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number890.5650
Classification Product Code
IRP  
Date Received12/04/2020
Decision Date 12/22/2020
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
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