Cleared Traditional

NURSE'S AID PATIENT ROTATION SYSTEM

K973624 · Air Med Assist Products · Physical Medicine

Jan 1998

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K973624 is an FDA 510(k) clearance for the NURSE'S AID PATIENT ROTATION SYSTEM, a Bed, Flotation Therapy, Powered (Class II — Special Controls, product code IOQ), submitted by Air Med Assist Products (Toole, US). The FDA issued a Cleared decision on January 21, 1998, 120 days after receiving the submission on September 23, 1997. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5170.

Submission Details

510(k) Number	K973624 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 1997
Decision Date	January 21, 1998
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF