Cleared Traditional

PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM

K040772 · Penner Manufacturing, Inc. · Physical Medicine

Apr 2004

Decision

10d

Days

Class 2

Risk

About This 510(k) Submission

K040772 is an FDA 510(k) clearance for the PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM, a Bath, Hydro-massage (Class II — Special Controls, product code ILJ), submitted by Penner Manufacturing, Inc. (Ohaha, US). The FDA issued a Cleared decision on April 5, 2004, 10 days after receiving the submission on March 26, 2004. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5100.

Submission Details

510(k) Number	K040772 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 2004
Decision Date	April 05, 2004
Days to Decision	10 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement