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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
Applicant
Lifestand
10925 Beamer #290
Houston,  TX  77089
Applicant Contact STEFANIE D BANKSTON
Correspondent
Lifestand
10925 Beamer #290
Houston,  TX  77089
Correspondent 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 Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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