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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, Peripheral, Electric
510(k) Number K861091
Device Name EASISTIM
Applicant
Promed Corp.
700 Larkspur Landing Cir.
Suite 199
Larkspur,  CA  94939
Applicant Contact PING YEE
Correspondent
Promed Corp.
700 Larkspur Landing Cir.
Suite 199
Larkspur,  CA  94939
Correspondent Contact PING YEE
Regulation Number868.2775
Classification Product Code
KOI  
Date Received03/24/1986
Decision Date 06/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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