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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 K133483
Device Name PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE
Applicant
Portable Therapeutix
2001 Honor Ave.
Ashland,  MA  01721
Applicant Contact Sharyn Orton, Ph.D.
Correspondent
Portable Therapeutix
2001 Honor Ave.
Ashland,  MA  01721
Correspondent Contact Sharyn Orton, Ph.D.
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Code
IME  
Date Received11/13/2013
Decision Date 03/11/2014
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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