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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K072887
Device Name G-TRAINER MEDICAL
Applicant
Alter-G, Inc.
1090a O'Brien Dr.
Menlo Park,  CA  94025
Applicant Contact GLEN MANGSETH
Correspondent
Alter-G, Inc.
1090a O'Brien Dr.
Menlo Park,  CA  94025
Correspondent Contact GLEN MANGSETH
Regulation Number890.5380
Classification Product Code
BXB  
Date Received10/10/2007
Decision Date 01/25/2008
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
Recalls CDRH Recalls
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