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FDA 510(k) Application Details - K133483
Device Classification Name
Massager, Powered Inflatable Tube
More FDA Info for this Device
510(K) Number
K133483
Device Name
Massager, Powered Inflatable Tube
Applicant
PORTABLE THERAPEUTIX
2001 HONOR AVE.
ASHLAND, MA 01721 US
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Contact
Sharyn Orton, Ph.D.
Other 510(k) Applications for this Contact
Regulation Number
890.5650
More FDA Info for this Regulation Number
Classification Product Code
IRP
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More FDA Info for this Product Code
Date Received
11/13/2013
Decision Date
03/11/2014
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
N
Expedited Review
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