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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Equipment, Traction, Powered
510(k) Number K010292
Device Name DRX 2000
Applicant
Axiom Worldwide, Inc.
3830 Gunn Hwy.
Tampa,  FL  33364
Applicant Contact JIM GIBSON
Correspondent
Axiom Worldwide, Inc.
3830 Gunn Hwy.
Tampa,  FL  33364
Correspondent Contact JIM GIBSON
Regulation Number890.5900
Classification Product Code
ITH  
Date Received01/31/2001
Decision Date 05/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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