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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 K865054
Device Name STIMUTRON MODEL 100
Applicant
The Austin-Lenick Co.
1809 Grace Ave.
P.O. Box 5066
Ft. Myers,  FL  33901
Applicant Contact DEBORAH LENICK
Correspondent
The Austin-Lenick Co.
1809 Grace Ave.
P.O. Box 5066
Ft. Myers,  FL  33901
Correspondent Contact DEBORAH LENICK
Regulation Number890.5850
Classification Product Code
IPF  
Date Received12/24/1986
Decision Date 02/26/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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