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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K915321
Device Name BTM-200 (PROPOSED) POWERED MUSCLE STIMULATOR
Applicant
Bt Medical Co., Inc.
C/O Malloy, Noblitt & Rueland
5405 Alton Pkwy., Suite A530
Irvine,  CA  92714
Applicant Contact JOHN J MALLOY
Correspondent
Bt Medical Co., Inc.
C/O Malloy, Noblitt & Rueland
5405 Alton Pkwy., Suite A530
Irvine,  CA  92714
Correspondent Contact JOHN J MALLOY
Regulation Number890.5850
Classification Product Code
IPF  
Date Received11/22/1991
Decision Date 07/17/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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