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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 K013061
Device Name BIOTOUCH MASSAGE THERAPY SYSTEM
Applicant
TACTILE SYSTEMS TECHNOLOGY INC
1074 LEGION ST.
SHAKOPEE,  MN  55379
Applicant Contact ERIC MCKEE
Correspondent
TACTILE SYSTEMS TECHNOLOGY INC
1074 LEGION ST.
SHAKOPEE,  MN  55379
Correspondent Contact ERIC MCKEE
Regulation Number890.5650
Classification Product Code
IRP  
Date Received09/11/2001
Decision Date 07/01/2002
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
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