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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, discharge, electrostatic (for pain relief)
510(k) Number K013094
Device Name ORTHOSONIX ENERGEX
Applicant
ORTHOSONIX, INC.
615 7TH ST. NE
1ST FLOOR
WASHINGTON,  DC  20002
Applicant Contact RUSSELL PAGANO
Correspondent
ORTHOSONIX, INC.
615 7TH ST. NE
1ST FLOOR
WASHINGTON,  DC  20002
Correspondent Contact RUSSELL PAGANO
Regulation Number890.5500
Classification Product Code
NHH  
Date Received09/17/2001
Decision Date 12/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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