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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K050687
Device Name AXIOM EPS8000
Applicant
Axiom Worldwide, Inc.
9423 Corporate Lake Dr.
Tampa,  FL  33634
Applicant Contact JAMES J GIBSON
Correspondent
Axiom Worldwide, Inc.
9423 Corporate Lake Dr.
Tampa,  FL  33634
Correspondent Contact JAMES J GIBSON
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GXY   LIH  
Date Received03/17/2005
Decision Date 07/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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