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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wheelchair, standup
510(k) Number K042596
Device Name LSA HELIUM
Original Applicant
LIFESTAND
10925 beamer #290
houston,  TX  77089
Original Contact stefanie d bankston
Regulation Number890.3900
Classification Product Code
IPL  
Date Received09/23/2004
Decision Date 01/26/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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