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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Goniometer, Ac-Powered
510(k) Number K862128
Device Name DIGITAL ELECTRONIC MYO-GRAPH (MUSCLE ANALYZER)
Applicant
Health Products, Inc.
1383-30 Veterans Memorial Hgwy
Hauppauge,  NY  11788
Applicant Contact DEL GIORNO
Correspondent
Health Products, Inc.
1383-30 Veterans Memorial Hgwy
Hauppauge,  NY  11788
Correspondent Contact DEL GIORNO
Regulation Number888.1500
Classification Product Code
KQX  
Date Received06/04/1986
Decision Date 07/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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