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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perineometer
510(k) Number K945937
Device Name TE-800 PELVIC FLOOR EXERCISER
Applicant
Myo/Kinetic Systems, Inc.
N84 W13562 Leon Rd.
Menomonee Falls,  WI  53051
Applicant Contact GREGORY L JOHNSON
Correspondent
Myo/Kinetic Systems, Inc.
N84 W13562 Leon Rd.
Menomonee Falls,  WI  53051
Correspondent Contact GREGORY L JOHNSON
Regulation Number884.1425
Classification Product Code
HIR  
Date Received12/05/1994
Decision Date 07/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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