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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K040457
Device Name NOMAD FROM DYNAMIS MOBILITY LTD.
Applicant
DYNAMIS MOBILITY LTD.
2765 THAMESGATE DR.
MISSISSAUGA, ONTARIO,  CA L4T 1G5
Applicant Contact RUTH LYTLE
Correspondent
DYNAMIS MOBILITY LTD.
2765 THAMESGATE DR.
MISSISSAUGA, ONTARIO,  CA L4T 1G5
Correspondent Contact RUTH LYTLE
Regulation Number890.3860
Classification Product Code
ITI  
Date Received02/23/2004
Decision Date 05/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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