Cleared Traditional

BANTAM

K091242 · Altimate Medical, Inc. · Physical Medicine

Jul 2009

Decision

69d

Days

Class 2

Risk

About This 510(k) Submission

K091242 is an FDA 510(k) clearance for the BANTAM, a Chair, Positioning, Electric (Class II — Special Controls, product code INO), submitted by Altimate Medical, Inc. (Elyria, US). The FDA issued a Cleared decision on July 6, 2009, 69 days after receiving the submission on April 28, 2009. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3110.

Submission Details

510(k) Number	K091242 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 2009
Decision Date	July 06, 2009
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF