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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 drive
tampa,  FL  33634
Applicant Contact james j gibson
Correspondent
AXIOM WORLDWIDE, INC.
9423 corporate lake drive
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
Recalls CDRH Recalls
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