Cleared Traditional

G-TRAINER MEDICAL

K072887 · Alter-G, Inc. · Physical Medicine

Jan 2008

Decision

107d

Days

Class 1

Risk

About This 510(k) Submission

K072887 is an FDA 510(k) clearance for the G-TRAINER MEDICAL, a Exerciser, Powered (Class I — General Controls, product code BXB), submitted by Alter-G, Inc. (Menlo Park, US). The FDA issued a Cleared decision on January 25, 2008, 107 days after receiving the submission on October 10, 2007. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number	K072887 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 10, 2007
Decision Date	January 25, 2008
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF