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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 K123829
Device Name PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK
Applicant
Portable Therapeutix, LLC
200 Homer Ave.,
Ashland,  MA  01721
Applicant Contact Sharyn Orton
Correspondent
Portable Therapeutix, LLC
200 Homer Ave.,
Ashland,  MA  01721
Correspondent Contact Sharyn Orton
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Code
IME  
Date Received12/12/2012
Decision Date 04/03/2013
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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