Cleared Traditional

TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2

K122473 · Hill-Rom · Physical Medicine

Jun 2013

Decision

293d

Days

Class 2

Risk

About This 510(k) Submission

K122473 is an FDA 510(k) clearance for the TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2, a Bed, Flotation Therapy, Powered (Class II — Special Controls, product code IOQ), submitted by Hill-Rom (Batesville, US). The FDA issued a Cleared decision on June 3, 2013, 293 days after receiving the submission on August 14, 2012. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5170.

Submission Details

510(k) Number	K122473 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 2012
Decision Date	June 03, 2013
Days to Decision	293 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF