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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name interferential current therapy
510(k) Number K990129
Device Name TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR
Applicant
THERAPY LINK, INC.
P.O. BOX 192004
LENEXA,  KS  66215
Applicant Contact CRAIG SEYL
Correspondent
THERAPY LINK, INC.
P.O. BOX 192004
LENEXA,  KS  66215
Correspondent Contact CRAIG SEYL
Regulation Number882.5890
Classification Product Code
LIH  
Subsequent Product Code
IPF  
Date Received01/13/1999
Decision Date 04/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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