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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K870568
Device Name BIO-PROMPT(TM)
Applicant
Physical Health Devices, Inc.
17345 NW 62 Ct.
Miami,  FL  33015
Applicant Contact JOHN Y CHURCH
Correspondent
Physical Health Devices, Inc.
17345 NW 62 Ct.
Miami,  FL  33015
Correspondent Contact JOHN Y CHURCH
Regulation Number882.5050
Classification Product Code
HCC  
Date Received02/10/1987
Decision Date 08/04/1987
Decision Substantially Equivalent (SESE)
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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