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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 K182668
Device Name Rapid Reboot Compression Therapy System
Applicant
Rapid Reboot Recovery Products, LLC
1396 W 200 S Bldg. 2a
Lindon,  UT  84042
Applicant Contact David Johnson
Correspondent
FDA Consulting, LLC
1100 Del Lago Cir. #104
Palm Beach Gardens,  FL  33410
Correspondent Contact John F Gillespy
Regulation Number890.5650
Classification Product Code
IRP  
Date Received09/25/2018
Decision Date 12/14/2018
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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