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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 K844126
Device Name SONTEC II
Applicant
Sontec, Inc.
16548 Espola Rd.
Poway,  CA  92064
Applicant Contact EDWIN E SKILLIG
Correspondent
Sontec, Inc.
16548 Espola Rd.
Poway,  CA  92064
Correspondent Contact EDWIN E SKILLIG
Regulation Number890.5850
Classification Product Code
IPF  
Date Received10/23/1984
Decision Date 07/01/1985
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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