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FDA 510(k) Application Details - K203552
Device Classification Name
Massager, Powered Inflatable Tube
More FDA Info for this Device
510(K) Number
K203552
Device Name
Massager, Powered Inflatable Tube
Applicant
Rapid Reboot Recovery Products, LLC
1396 W 200 S, Building 2, Unit A
Lindon, UT 84042 US
Other 510(k) Applications for this Company
Contact
David Johnson
Other 510(k) Applications for this Contact
Regulation Number
890.5650
More FDA Info for this Regulation Number
Classification Product Code
IRP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/04/2020
Decision Date
12/22/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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