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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 K080221
Device Name EA STIMULATOR
Applicant
Helio Medical Supplies, Inc.
606 Charcot Ave.
San Jose,  CA  95131
Applicant Contact YUKUO HSO
Correspondent
Helio Medical Supplies, Inc.
606 Charcot Ave.
San Jose,  CA  95131
Correspondent Contact YUKUO HSO
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received01/29/2008
Decision Date 09/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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