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FDA 510(k) Application Details - K211460
Device Classification Name
Massager, Powered Inflatable Tube
More FDA Info for this Device
510(K) Number
K211460
Device Name
Massager, Powered Inflatable Tube
Applicant
Diode Art Engineering doing business as Air Relax
9535 Brasher St
Pico Rivera, CA 90660 US
Other 510(k) Applications for this Company
Contact
Beomjoon Lee
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
05/11/2021
Decision Date
05/25/2021
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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