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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K864370
Device Name DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR)
Applicant
Dynatronics Laser Corp.
470 Lawndale Dr., Bldg.
D
Salt Lake City,  UT  84115
Applicant Contact KELVYN H CULLIMORE
Correspondent
Dynatronics Laser Corp.
470 Lawndale Dr., Bldg.
D
Salt Lake City,  UT  84115
Correspondent Contact KELVYN H CULLIMORE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/05/1986
Decision Date 04/10/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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